![Relyvrio to be Withdrawn from US Markets After Disappointing ALS Study Results 2 urlhttps3A2F2Fassets.apnews.com2F1e2Fe22F732f7aaade6ab36400f550e6edea2F4bfc6ac2e73249e2b57453c6d674e8a9](https://i0.wp.com/theubj.com/uae/wp-content/uploads/2024/04/urlhttps3A2F2Fassets.apnews.com2F1e2Fe22F732f7aaade6ab36400f550e6edea2F4bfc6ac2e73249e2b57453c6d674e8a9.jpeg?w=1170)
The pharmaceutical company Amylyx has declared its intention to remove its ALS medication, Relyvrio, from the U.S. market after it was found ineffective in a comprehensive clinical trial. Amylyx made this decision public on Thursday, signalling an end to the drug’s availability for new patients in the United States and Canada.
Despite the setback, Amylyx is stopping sales with consideration for those afflicted with the life-threatening neurological disorder, amyotrophic lateral sclerosis (ALS), also known as Lou Gehrig’s disease. “Our commitment to people living with ALS remains unwavering, even as we face this challenging juncture,” said company representatives. A free program will be offered to patients currently on Relyvrio who choose to continue treatment.
Approved controversially by the Food and Drug Administration (FDA) in September 2022, Relyvrio initially came to market as a result of intensive advocacy by ALS patients. Its withdrawal follows a failed trial involving 600 participants that recorded no significant improvement in survival or functional ability, and it leaves only three ALS drugs on the market.
Amylyx’s voluntary withdrawal circumvents what could have become a regulatory conundrum for the FDA, which fully approved Relyvrio based on limited efficacy data from a single mid-stage study. Under usual circumstances, the FDA requires two comprehensive studies to confirm the efficacy of a drug before approval.
Typically fatal within a few years of diagnosis, ALS erodes muscle function and autonomy, and is part of a group of degenerative illnesses for which several drugs have recently received FDA approval—despite inconclusive evidence of their effectiveness.
At $158,000 per annual supply, Relyvrio’s price tag sparked additional criticism, further hampered by poor sales and patients quitting the treatment prematurely.
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This coverage by The Associated Press Health and Science Department is backed by the Howard Hughes Medical Institute’s Science and Educational Media Group, though all content is independently produced by the AP.
FAQs about Relyvrio and ALS Treatment
Q: What is Relyvrio?
A: Relyvrio is a medication that was designed to treat ALS. It is composed of two drugs: one for liver disorders and a dietary supplement used in traditional Chinese medicine, mixed into a powder form.
Q: Why is Relyvrio being withdrawn from the market?
A: The drug is being removed from the market after a large-scale clinical trial failed to show benefits in terms of survival or improvement in muscle strength and walking ability for ALS patients.
Q: Can patients who are currently taking Relyvrio continue their treatment?
A: Yes, patients currently on Relyvrio have the option to enroll in a program that will provide them the drug for free.
Q: How many ALS medications are now available in the U.S.?
A: With the removal of Relyvrio, there will be three approved medications remaining for the treatment of ALS in the U.S.
Conclusion
The withdrawal of Relyvrio from the market represents a significant setback in the treatment options for ALS. Amylyx Pharmaceuticals’ decision highlights the ongoing challenges in developing effective therapies for this devastating disease. Although the FDA’s initial approval offered hope, the drug’s subsequent failure underscores the need for rigorous clinical trials and the importance of finding reliable treatments that truly benefit patients with degenerative diseases like ALS. Amylyx’s commitment to providing Relyvrio for free to those already under treatment is a silver lining for patients who wish to continue on their established regimen.