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June 2023

FMA International Recalls SAS Fromagerie Ottavi Tome Corse Sheep Milk Cheese Imported From France Because of Possible Health Risk

Summary

Product Type:  Food & Beverages
Cheese/Cheese Product
Foodborne Illness
Reason for Announcement: Potential Foodborne Illness
Company Name:  Food Matters Again International
Brand Name: SAS Fromergerie Ottavi
Product Description: Tome Corse Sheep Milk Cheese

Company Announcement

FMA International of Brooklyn, NY is recalling one lot of SAS Fromagerie Ottavi Tome Corse Sheep Milk Cheese, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.

FMA International imported a total of one case from the affected lot. 
Ottavi Tome Corse cheese was distributed in the state of Oregon to a specialty food distributor. The one case from the recalled lot has since been accounted for and has been subsequently destroyed. It was never sold to any retailers or restaurants.

Product

Lot

Expiration

Fromagerie Ottavi Tome Corse Sheep Milk Cheese – circular wheels of cheese
weighing approximately 6 lbs.
VC349 07/08/2023

  This cheese is associated with an ongoing outbreak of Listeria monocytogenes infections in Europe.

The recall was the result of an ongoing recall and outbreak of Listeria monocytogenes in Europe associated with cheese from SAS Fromagerie Ottavi. FMA International was notified by the France manufacturer and immediately recalled the cheese imported to the United States.

Consumers who have purchased SAS Fromagerie Tome Corse should not consume or distribute the product and are urged to return it to the place of purchase for a full refund. Consumers with questions may contact Food Matters Again at 718-361-3183, Monday through Friday, from 9am to 5pm EST.


Company Contact Information

Consumers:
Food Matters Again
718-361-3183

The Bachelor on the Cheap Gluten-Free Diet Challenge 2023 - Day 30

BachelorontheCheap.com

Wow, 30 days in already.  My, time flies when you're having diet 'fun'...  Seriously though, I'm not feeling like I'm on some kind of restricted diet with a very short list of menu options.  On the contrary, I've enjoyed the foods I've prepared, sampled, and reviewed and the variety has been excellent.  Most importantly, the omission of wheat products hasn't been all that difficult to do, the cravings for them have been minimal and the gluten-free substitutes for the most part have been tasty. 

Here's the Day 30 menu:

GF Diet Day 30

It was another very low-calorie day and I think my body has become accustomed to it with a focus on protein.  I don't get uncomfortably hungry between meals.  It was also another no-red-meat day, which I'm also finding fairly easy to do, cravings are minimal.  Perhaps feeling better being gluten-free and seeing the weight coming off eclipses a desire for certain foods.  Bonus:  Saving money!

$pend Wisely My Friends...

~ Mike


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The Bachelor on the Cheap Gluten-Free Diet Challenge 2023 - Day 29, a totally meatless day, oh, and no wheat

BachelorontheCheap.com

Today was a very low-calorie day, but I didn't feel uncomfortably hungry at any point.  I really didn't think much of it and my stomach didn't send out any urgent "feed me" signals.

GF Diet Day 29

The day was meatless, in addition to being gluten-free.  I didn't get near the protein I typically do, but I am very happy with the calorie count and the lack of feeling hungry.

Today was a weigh-in day and I'm pleased to report another 2-pound drop, for a total loss of 8 pounds since starting this diet on May 27.  Eating right, doing some exercise, and not drinking soda or alcohol have led to a consistent 2-pound drop in weight every week.

Being a meatless day, the menu was very budget-friendly.  The most expensive item on the list was the french fries, purchased from a food truck and consumed during a visit to a local greenhouse hosting an event.

$pend Wisely My Friends...

~ Mike

Enjoy this post?

If you appreciate this cost comparison and want to support more great content on BachelorontheCheap.com, you can help keep this site going with a one-time or monthly donation.  Thank you so much for your support! ~ Mike

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Facebook


The Bachelor on the Cheap Gluten-Free Diet Challenge 2023 - Day 28, a no bread, no wheat, no red meat day!

BachelorontheCheap.com

In addition to not eating any wheat products, today was a no-red-meat day. 

GF Diet Day 28

As I did yesterday, I split what is traditionally a meal together, in this case, salmon over a bed of pasta, into two meals.  I had the salmon for the morning snack (and I was pretty hungry after having just 2 ounces of Colby Jack cheese for breakfast!), and some chickpea pasta tossed in garlic butter and Parmesan for lunch.  The chickpea pasta packs 19 grams of protein per serving!

Back in the day, I used to be a meat 3+ meals a day guy and it was usually red meat.  I love my protein!  So check out the protein count for today, done without eating any red meat.  And overall, the cravings for regular bread, pasta, crackers, and the like have been minimal and when I do have those cravings, GF products or other non-wheat alternatives have addressed the cravings.

$pend Wisely My Friends...

~ Mike

Enjoy this post?

If you appreciate this cost comparison and want to support more great content on BachelorontheCheap.com, you can help keep this site going with a one-time or monthly donation.  Thank you so much for your support! ~ Mike

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Scenic Fruit Company Recalls Organic Pineapple Because of Possible Health Risk

Summary

Product Type:  Food & Beverages
Reason for Announcement: Potential to be contaminated with Listeria monocytogenes.
Company Name:  Scenic Fruit Company
Brand Name: Cadia and Trader Joe’s
Product Description: Organic Frozen Pineapple and Frozen Fruit Blend Containing Organic Frozen Pineapple

Company Announcement

Trader Joe's FruitScenic Fruit Company of Gresham, Oregon is recalling frozen organic pineapple and frozen fruit blends containing organic pineapple as the product has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, listeria infection can cause miscarriages and stillbirths among pregnant women.

Recalled products were sold at Trader Joe’s retail stores, nationwide, and Health Food stores in CA, IL, IN, FL, MD, OR and TX.

Brand Name Product Name Net Wt. UPC Best By Date
Best If Use
Dates Best
Before Date
Lot No. Distributed in States
Cadia Organic Pineapple 10 oz 815369014540 05/12/2024
09/08/2024
B2243316
C0305067
CA, IL, IN, FL, MD, OR, and TX.
Trader Joe’s Organic Tropical Fruit Blend
(Pineapple, Banana, Strawberry, Mango)
16 oz 00511919 04/24/24
08/04/24
10/13/24
11/04/24
B22098297
C20171035
C20450103
C20511124
Nationwide

The recall is being initiated in response to Sunrise Growers Inc.’s recall due to the potential presence of Listeria monocytogenes.

To date, there have been no illnesses associated with this voluntary recall.

This recall is being made with the knowledge of the U.S. Food and Drug Administration (FDA).

All inventories of the affected lot should be removed from sale.

Consumers should not consume the recalled products. Consumers who have purchased the products are urged to destroy or return it to the place of purchase for a full refund. Consumers with questions may contact the company at [email protected].


Company Contact Information

Consumers:
Scenic Fruit Company
[email protected]
 

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

Agency Recommendations Aim to Inform Psychedelic Drug Development

Today, the U.S. Food and Drug Administration published a new draft guidance to highlight fundamental considerations to researchers investigating the use of psychedelic drugs for potential treatment of medical conditions, including psychiatric or substance use disorders. This is the first FDA draft guidance that presents considerations to industry for designing clinical trials for psychedelic drugs.

There has been growing interest in the therapeutic potential of psychedelic drugs in recent years. They are being evaluated for use in the potential treatment of conditions such as depression, post-traumatic stress disorder, substance use disorders and other conditions. However, designing clinical studies to evaluate the safety and effectiveness of these compounds presents a number of unique challenges that require careful consideration.

“Psychedelic drugs show initial promise as potential treatments for mood, anxiety and substance use disorders. However, these are still investigational products. Sponsors evaluating the therapeutic potential of these drugs should consider their unique characteristics when designing clinical studies,” said Tiffany Farchione, M.D., director of the Division of Psychiatry in the FDA’s Center for Drug Evaluation and Research. “By publishing this draft guidance, the FDA hopes to outline the challenges inherent in designing psychedelic drug development programs and provide information on how to address these challenges. The goal is to help researchers design studies that will yield interpretable results that will be capable of supporting future drug applications.”

The purpose of the draft guidance is to advise researchers on study design and other considerations as they develop medications that contain psychedelics. Within the draft guidance, the term psychedelics refers to “classic psychedelics,” typically understood to be drugs such as psilocybin and lysergic acid diethylamide (LSD) that act on the brain’s serotonin system, as well as “entactogens” or “empathogens” such as methylenedioxymethamphetamine (MDMA).

The document describes basic considerations throughout the drug development process including trial conduct, data collection, subject safety and new drug application requirements. For example, psychedelic drugs may produce psychoactive effects such as mood and cognitive changes, as well as hallucinations. As a result, there is the potential for abuse of these drugs, which is a drug safety issue that requires careful consideration and putting sufficient safety measures in place for preventing misuse throughout clinical development. For psychedelics that are currently Schedule I controlled substances, the draft guidance notes that activities associated with investigations under an Investigational New Drug Application must comply with applicable Drug Enforcement Administration regulatory requirements.

The evidentiary standard for establishing effectiveness of psychedelic drugs is the same as for all other drugs. However, there are unique factors investigators may need to consider when designing their clinical trials if those trials are to be considered adequate and well-controlled. The draft guidance also addresses the role of psychotherapy in psychedelic drug development, considerations for safety monitoring and the importance of characterizing dose-response and the durability of any treatment effect. 

The FDA is encouraging the public to provide comments on the draft guidance. Comments should be submitted within 60 days to ensure the agency considers them. 

Related Information

###

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


The Bachelor on the Cheap Gluten-Free Diet Challenge 2023 - Day 27

BachelorontheCheap.com

Wow, what a high-carb day!  In chasing a craving, I went WAY over my target of fewer than 60 grams of carbs per day and never mind the whopping 830 calories - OMG!  What can I say, it's been a while since I've had hash browns, tater tots, that kind of thing, and hitting the drive-thru at Spangles satisfied that craving.  It's out of my system, for a while anyway.  Treating it like a treat, and not a regular menu item... Eating the chickpea pasta didn't help with the day's carb count either.

Here's the Day 27 menu:


GF Diet Day 27

In tweaking this diet as I go along, I've found it pretty easy to break a meal into two parts.  For example, a normal breakfast back in the day would have been some kind of breakfast sandwich, AND a side of hashbrowns or tots, washing it all down with a cup (OK, two) of Joe.   Today, I split that menu, having the tots for breakfast, and the sausage, egg, and cheese (no biscuit or croissant) for the morning snack.  Portion control, in addition to the elimination of gluten, has helped my body burn fuel more efficiently.

On the day, the calorie count was good and the protein count wasn't bad, a bit low, but not bad.  In addition to supplementing my diet with a daily vitamin, I started drinking lime water (yes, using real lime juice, not the fake stuff ) to get some additional fruit nutrition in.

If you noticed, Ive been making an effort in recent days to reduce my intake of red meat.

$pend Wisely My Friends...

~ Mike

Enjoy this post?

If you appreciate this cost comparison and want to support more great content on BachelorontheCheap.com, you can help keep this site going with a one-time or monthly donation.  Thank you so much for your support! ~ Mike

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Voluntary Recall of Specific Frozen Fruit Products Due to Possible Contamination by Listeria monocytogenes

Summary

Product Type:  Food & Beverages
Fruit/Fruit Product
Foodborne Illness
Reason for Announcement: Potential for Listeria monocytogenes contamination
Company Name:  SunOpta Inc.
Brand Name: Multiple brand names
Product Description: Frozen Fruit

Company Announcement

Mixed FruitMinneapolis, Minn. – SunOpta Inc’s subsidiary, Sunrise Growers Inc., has issued a voluntary recall of specific frozen fruit products linked to pineapple provided by a third-party supplier due to the potential for these products to be contaminated with Listeria monocytogenes.

Listeria monocytogenes is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women. Any consumers concerned about an illness should contact a physician.

Products were distributed via the following retailers:

  • Walmart: Great Value Mixed Fruit, Great Value Dark Sweet Cherries, and Great Value Mango Chunks sold at stores in AR, AZ, CA, CO, DC, IA, ID, IL, IN, KS, KY, LA, MD, MN, MO, MT, ND, NE, NM, NV, OH, OK, OR, PA, SD, TX, UT, VA, WV and WY from January 19, 2023 to June 13, 2023
  • Whole Foods: 365 Organic Tropical Fruit Medley, 365 Organic Pineapple Chunks, 365 Pineapple Chunks, 365 Organic Whole Strawberries, 365 Organic Slice Strawberries and Bananas, and 365 Organic Blackberries distributed to select stores throughout the US from November 1, 2022 to June 21, 2023
  • Trader Joe’s: Trader Joe’s Organic Tropical Fruit Blend distributed to select distribution centers or stores in AK, AL, CT, CO, DE, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, NE, NH, NJ, NM, NY, OH, OK, PA, RI, TN, TX, VA, VT, WI, and Washington DC from March 28, 2023 to April 11, 2023
  • Target: Good & Gather Organic Cherries and Berries Fruit Blend, Good & Gather Dark Sweet Whole Pitted Cherries, Good & Gather Mango Strawberry Blend, Good & Gather Mixed Fruit Blend, Good & Gather Mango Chunks, Good & Gather Blueberries, and Good & Gather Triple Berry Blend distributed nationwide from October 14, 2022 to May 22, 2023
  • Aldi: Season’s Choice Tropical Blend distributed to select distribution centers or stores in AL, AR, CT, FL, GA, IA, KS, KY, MA, MD, MI, MO, MS, NC, NE, NH, NY, OH, OK, PA, RI, SC, TN, TX, VA, VT and WV from October 11, 2022 to May 22, 2023
  • AWG (Associated Wholesale Grocers): Best Choice Pitted Red Tart Cherries Unsweetened distributed to select distribution centers or stores in KS, MO, NE and OK from April 5, 2023 to May 4, 2023

To date, there have been no illnesses associated with this voluntary recall.

This voluntary recall includes the following code dates currently in stores or consumers’ freezers:

Walmart
Great Value Mixed Fruit packaged in a 16-ounce plastic bag (70,360 cases) with the following codes:

Lot

Best By

Lot

Best By

Lot

Best By

FMX235003 12/16/2024 FMX300902 01/09/2025 FMX303313 02/02/2025
FMX235101 12/17/2024 FMX301806 01/18/2025 FMX303803 02/07/2025
FMX303903 02/08/2025 FMX304102 02/09/2025 FMX305202 02/21/2025
FMX304003 02/09/2025 FMX305102 02/20/2025 FMX305302 02/22/2025
FMX305401 02/23/2025 FMX306907 03/10/2025 FED306861 03/09/2025
FED306961 03/10/2025        

Great Value Dark Sweet Cherries packaged in16-ounce plastic bag (3,305 cases) with the following codes:

Lot

Best By

FED308962 03/30/2025

Great Value Mango Chunks packaged in a 16-ounce plastic bag (8,569 cases) with the following codes:

Lot

Best By

FED306161 03/02/2025

Whole Foods
365 Organic Tropical Fruit Medley packaged in a 32-ounce plastic bag (34,578 cases) with the following codes:

Lot

Best By

Lot

Best By

Lot

Best By

FED302652 01/26/2024 FED228452 10/11/2023 FED305351 02/22/2024
FED302751 01/27/2024 FED228551 10/12/2023 FED312452 05/03/2024
FED231851 11/14/2023        

365 Organic Pineapple Chunks packaged in a 10-ounce plastic bag (14,946 cases) with the following codes:

Lot

Best By

Lot

Best By

Lot

Best By

FED303011 01/30/2025 FED303131 01/31/2025 FED311631 04/26/2025
FED303111 01/31/2025 FED307531 03/16/2025 FED225511 09/12/2024
FED225611 09/13/2024 FED225711 09/14/2024 FED225811 09/15/2024

365 Pineapple Chunks packaged in a 16-ounce plastic bag (8,049 cases) with the following codes:

Lot

Best By

Lot

Best By

Lot

Best By

FED303132 01/31/2025 FED303231 02/01/2025 FED307532 03/16/2025
FED303133 01/31/2025 FED303431 02/03/2025 FED307631 03/17/2025

365 Organic Whole Strawberries packaged in a 32-ounce plastic bag (13,017 cases) with the following codes:

Lot

Best By

FED305451 02/23/2025
FED305551 02/24/2025

365 Organic Sliced Strawberries and Bananas packaged in a 32-ounce plastic bag (3,691 cases) with the following codes:

Lot

Best By

FED310852 04/18/2024
FED310951 04/19/2024

365 Organic Blackberries packaged in a 10-ounce plastic bag (2,181 cases) with the following codes:

Lot

Best By

FED225911 09/16/2024

Trader Joe’s
Trader Joe’s Organic Tropical Fruit Blend packaged in a 16-ounce plastic bag (2,588 cases) with the following codes:

Lot

Best By

Lot

Best By

Lot

Best By

FMX303005 01/30/24 FMX303204 02/01/24 FMX303401 02/03/24
FMX303105 01/31/24 FMX303301 02/02/24    

Target
Good & Gather Organic Cherries and Berries Fruit Blend packaged in a 32-ounce plastic bag (3,961 cases) with the following codes:

Lot

Best By

FED305552 02/24/2025

Good & Gather Dark Sweet Whole Pitted Cherries packaged in a 12-ounce plastic bag (1,515 cases) with the following codes:

Lot

Best By

FED308862 03/29/2025

Good & Gather Mango Strawberry Blend packaged in a 48-ounce plastic bag (238 cases) with the following codes:

Lot

Best By

FED308351 03/24/2025

Good & Gather Mixed Fruit Blend packaged in a 48-ounce plastic bag (8,178 cases) with the following codes:

Lot

Best By

FED308153 03/22/2025
FED308251 03/23/2025
FED308951 03/30/2025

Good & Gather Mango Chunks packaged in a 12-ounce plastic bag (871 cases) with the following codes:

Lot

Best By

FED308661 03/27/2025

Good & Gather Blueberries packaged in a 48-ounce plastic bag (5,344 cases) with the following codes:

Lot

Best By

FED228651 10/13/2023

Good & Gather Triple Berry Blend packaged in a 48-ounce plastic bag (6,034 cases) with the following codes:

Lot

Best By

FED228652 10/13/2023
FED228751 10/14/2023

Aldi
Season’s Choice Tropical Blend and Mixed Fruit packaged in a 32-ounce plastic bag (38,909) with the following codes: 

Lot

Best By

Lot

Best By

Lot

Best By

FMX234011 12/06/2024 FMX235501 12/21/2024 FMX236202 12/28/2024
FMX234103 12/07/2024 FMX236001 12/26/2024 FMX236301 12/29/2024
FMX234211 12/08/2024 FMX236102 12/27/2024 FMX301208 01/12/2025
FMX303101 01/31/2025 FMX303201 02/01/2025 FMX301302 01/13/2025
FMX301402 01/14/2025 FMX303001 01/30/2025 FMX230704 11/03/2024
FMX230707 11/03/2024 FMX231804 11/14/2024 FMX227605 10/03/2024
FMX227705 10/04/2024        

AWG (Associated Wholesale Grocers)
Best Choice Pitted Red Tart Cherries Unsweetened packaged in a 12-ounce plastic bag (1,088 cases) with the following code:

Lot

Best By

FED308861 03/29/2025

Consumers are urged to check their freezers for the recalled product, not to consume it and either discard the product or return it to the store for a full refund. All other Sunrise Growers products that have different lot codes or best by dates are not affected by this recall. The affected retail customers have been notified of this recall and instructed to remove any recalled product from retail store shelves and inventories.

Consumers seeking information may email [email protected] or call 1.888.490.5591 Monday through Friday, 8:00 a.m. to 5:00 p.m. Pacific Time.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

Our commitment to food safety remains our utmost priority. Sunrise Growers has terminated all future business with the third-party supplier.

About SunOpta

SunOpta (Nasdaq:STKL) (TSX:SOY) is a U.S.-based, global pioneer fueling the future of sustainable, plant-based and fruit-based food and beverages. Founded nearly 50 years ago, SunOpta manufactures natural, organic and specialty products sold through retail and foodservice channels. SunOpta operates as a manufacturer for leading natural and private label brands, and also proudly produces its own brands, including SOWN®, Dream®, West Life™ and Sunrise Growers®. For more information, visit www.sunopta.comExternal Link Disclaimer and LinkedIn.


Company Contact Information

Consumers:
Customer Service
1.888.490.5591
[email protected]
Media:
Konnect Agency
213-988-8344
[email protected]

FDA Approves First Gene Therapy for Treatment of Certain Patients with Duchenne Muscular Dystrophy

Today, the U.S. Food and Drug Administration approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 through 5 years of age with Duchenne muscular dystrophy (DMD) with a confirmed mutation in the DMD gene who do not have a pre-existing medical reason preventing treatment with this therapy. 

“Today’s approval addresses an urgent unmet medical need and is an important advancement in the treatment of Duchenne muscular dystrophy, a devastating condition with limited treatment options, that leads to a progressive deterioration of an individual’s health over time,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA remains committed to facilitating the development of innovative new therapies to reduce the impact of debilitating diseases and to improve outcomes and quality of life for those affected.”

Duchenne muscular dystrophy is a rare and serious genetic condition which worsens over time, leading to weakness and wasting away of the body’s muscles. The disease occurs due to a defective gene that results in absence of dystrophin, a protein that helps keep the body’s muscle cells intact. As a result of this genetic defect, individuals with DMD may have symptoms such as trouble walking and running, falling frequently, fatigue, learning disabilities/difficulties, heart issues as a result of impact on heart muscle functioning, and breathing problems due to weakening of respiratory muscles involved in lung function. Symptoms of muscle weakness associated with DMD typically begin in childhood, often between 3 to 6 years of age. DMD mainly affects males and in rare cases may affect females. About one in every 3,300 boys are affected by this disorder. As the disease progresses, life-threatening heart and respiratory problems can occur. Although disease severity and life expectancy vary, patients often succumb to the disease in their 20s or 30s because of heart and/or respiratory failure. Most current treatment approaches address the symptoms of the disease, but not its underlying genetic cause. Treatments include corticosteroid medications to slow down the progression of muscle weakness, stretching and exercise programs, and use of equipment such as braces or a wheelchair as walking becomes more difficult. Antisense oligonucleotides (ASOs) facilitate exon skipping for specific DMD gene mutations, but the ASOs can only address a minority of the gene mutations and require repeated administration.  

Elevidys is a recombinant gene therapy designed to deliver into the body a gene that leads to production of Elevidys micro-dystrophin, a shortened protein (138 kDa, compared to the 427 kDa dystrophin protein of normal muscle cells) that contains selected domains of the dystrophin protein present in normal muscle cells. The product is administered as a single intravenous dose. 

Elevidys was approved through the Accelerated Approval pathway, under which the FDA may approve drugs for serious or life-threatening diseases where there is an unmet medical need and the drug is shown to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit to patients (improving how patients feel or function, or whether they survive longer), or an effect on a clinical endpoint that can be measured earlier than irreversible morbidity or mortality that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. This pathway generally provides patients earlier access to promising new drugs while the company conducts clinical trials to verify the predicted clinical benefit.

The FDA granted approval based on an evaluation of data submitted by the sponsor. In one study which involved two parts, individuals in part 1—which was randomized, double-blind, and placebo-controlled—were treated with either Elevidys or placebo and followed for 48 weeks. In part 2 of the study, individuals who received placebo during part 1 were treated with Elevidys, and individuals treated with Elevidys during part 1 received a placebo. All individuals were followed for an additional 48 weeks. 

The accelerated approval of Elevidys was based on data from the randomized clinical trial that established that Elevidys increased the expression of the Elevidys micro-dystrophin protein observed in Elevidys-treated individuals aged 4 to 5 years with DMD. The FDA concluded that the data submitted by the applicant demonstrated that an increase in this surrogate endpoint (expression of Elevidys micro-dystrophin) is reasonably likely to predict clinical benefit in individuals 4 to 5 years of age with DMD who do not have significant pre-existing antibody titers against the AAV rh74 vector or have other contraindications based on the inclusion criteria of the clinical trials. 

In making this decision, the FDA considered the potential risks associated with the drug, the life-threatening and debilitating nature of the disease for these children, and the urgent unmet medical need. 

A clinical benefit of Elevidys, including improved motor function, has not been established. As a condition of approval, the FDA is requiring the company to complete a clinical study to confirm the drug’s clinical benefit. The required study is designed to assess whether Elevidys improves physical function and mobility in ambulatory DMD patients with a confirmed mutation in the DMD gene. The study is ongoing and fully enrolled. The agency will review the data from this trial as quickly as possible to consider if further action, such as a revised indication or withdrawal of Elevidys, may be necessary.

The most commonly reported side effects by individuals who received Elevidys were vomiting, nausea, acute liver injury, pyrexia (fever) and thrombocytopenia (abnormally low platelet count in the blood). Patients’ liver function should be monitored before treatment with Elevidys, and weekly for the first three months after treatment. Patients given Elevidys may also be at risk for severe immune-mediated myositis (muscle inflammation). Additionally, myocarditis (inflammation of heart muscle) and elevations of troponin-I (a heart protein found in the blood after heart muscle injury) have been observed following use of Elevidys in clinical trials. Troponin-I levels should be monitored before administration of Elevidys and weekly for the first month after treatment. 

The FDA granted accelerated approval of Elevidys to Sarepta Therapeutics, Inc.

###

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.