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FDA Approves Amylyx's ALS Drug

Amylyx Pharmaceuticals Inc. (AMLX) said Thursday that the U.S. Food and Drug Administration has approved Relyvrio for the treatment of adults with amyotrophic lateral sclerosis or ALS.

Relyvrio significantly slowed the loss of physical function in people living with amyotrophic lateral sclerosis in a randomized, placebo-controlled clinical trial. Relyvrio can be taken as a monotherapy or with existing approved treatments, the company said in a statement.

AMLX closed Thursday regular trading at $30.19 up $0.96 or 3.28%. In the after-hours trading, the stock further gained $2.82 or 9.34%.

Amyotrophic lateral sclerosis is a rare disease that attacks and kills the nerve cells that control voluntary muscles. Voluntary muscles produce movements such as chewing, walking, breathing, and talking. Amyotrophic lateral sclerosis causes the nerves to lose the ability to activate specific muscles, which causes the muscles to become weak and leads to paralysis.

Amyotrophic lateral sclerosis is a progressive disease that continues to get worse over time. Most cases will result in death from respiratory failure, usually within three to five years from when the symptoms first appear.

About 5,000 individuals in the United States are diagnosed with ALS annually, and about 20,000 Americans are currently living with the disease.

The most common adverse reactions experienced with Relyvrio were diarrhea, abdominal pain, nausea and upper respiratory tract infection. Relyvrio contains taurursodiol, a bile acid, which may cause worsening diarrhea in patients with disorders that interfere with bile acid circulation.

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