Drug Being Pulled Off Market After Trial Failure

Drug To Be Pulled Off Market After Trial Failure

(RepublicanView.org) – The creator of a drug billed to help treat Lou Gehrig’s disease will be pulled from the market after it failed a significant clinical study.

Amylyx Pharmaceuticals admitted that Relyvrio did nothing to help patients despite that it received approval from the Food & Drug Administration (FDA) in September 2022. The drug was already considered controversial ahead of its approval in the medical community. However, advocate groups and campaigns led by patients suffering from amyotrophic lateral sclerosis (ALS) reportedly pushed for the federal agency to approve the experimental drug anyway. The move sparked a debate about the FDA approving experimental treatments for terminal patients even when evidence is lacking.

There are now only three medications available to patients who suffer from the disease that causes muscular deterioration. One of them, Biogen, received the FDA’s greenlight in 2023 while also requiring more research into its efficacy. The injectable is the first that’s designed to treat a rare ALS form, SOD1-ALS. There are currently fewer than 500 Americans suffering from the condition. One of the FDA’s conditions for the early release of Biogen is to run clinical trials on patients who have the genetic mutation but are not experiencing symptoms yet.

Amylyx began considering removing Relyvrio from the market in March after it failed to help 600 patients improve their health and survival rates during clinical trials. The voluntary removal saves the FDA from revoking its approval, a process that can often be complicated. It was approved after a small study considered to only be in the middle stages. Several FDA scientists advised against approval, but the agency hoped it would offer relief and life-saving benefits for patients whose options were very limited.

A one year supply of the drug cost $158,000 at the time of its release. Several patients stopped taking it after just a few months, leading to lackluster sales for the manufacturer. It was essentially a combination of an old Chinese supplement and a liver disorder drug.

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