(NationalUSNews.com) — A medication for amyotrophic lateral sclerosis, also known as A.L.S., could be temporarily withheld from American markets due to a failed clinical trial. The Food and Drug Administration approved the drug Relyvrio in 2022, but manufacturers could halt its production due to its potential effects on people using it.
The FDA approved Relyvrio despite certain medical professionals believing the drug lacked effectiveness and posed a potential risk to A.L.S. patients. The FDA also failed to perform any trials for Relyvrio, pushing its production before medical practitioners had knowledge about its performance.
Although the FDA approved Relyvrio, manufacturers have not produced a large quantity of the medication, and only approximately 4,000 people have access to it. Patients take Relyvrio by mixing it into water and drinking the substance, which costs more than $150,000 annually. Despite the hefty price and the FDA’s approval, a recent clinical trial indicated that the majority of patients found Relyvrio as effective as a placebo. The shocking trial results prompted Relyvrio’s manufacturers to release a statement about the A.L.S. treatment.
According to Justin Klee, one of Amylyx’s CEOs, the drug manufacturer didn’t know about the A.L.S. treatment’s lack of efficacy. Klee then indicated that Amylyx is currently developing a plan for the future of the A.L.S. medication, which could result in the drug’s removal from the market. Klee claimed that Amylyx would work harder on developing a treatment for A.L.S. and work alongside groups like the FDA to prevent a similar mishap in the future.
Should Amylyx remove Relyvrio from the medication market, A.L.S. patients will have only two alternatives: riluzole and edaravone. Each medication can extend A.L.S. patients’ life expectancies or slow the disease from progressing rapidly, but neither provides a permanent cure nor a substantial reduction of A.L.S. symptoms. The FDA ignored the lack of a Relyvrio clinical trial as A.L.S. support groups campaigned for Relyvrio’s approval and A.L.S. patients testified about the drug’s efficacy.
The FDA did acknowledge the lack of evidence regarding Relyvrio’s performance when it approved the medication, raising a possibility of lawsuits from A.L.S. patients who used Relyvrio before medical experts could ensure its quality. So far, there hasn’t been any legal action against Amylyx or the FDA for failing to ensure Relyvrio works, but A.L.S. patients could pursue a lawsuit soon.
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