ALS drug wins FDA approval despite questionable data | amNewYork

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A much-debated drug for Lou Gehrig's disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines.

from ALS patients, advocates and members of Congress. In recent weeks the agency received more than 1,300 written comments from the ALS community supporting the treatment.

The powder-based drug is a combination of two older ingredients: a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine. Cambridge, Massachusetts-based Amylyx has patented the combination and says the chemicals work together to shield cells from premature death.

Amylyx did not immediately disclose the price Thursday but said it planned to announce the information on a call with investors Friday morning. In Canada, where the drug received approval in June, the company has proposed a price equating to $165,000. Sunny Brous was diagnosed with ALS in 2015 and hopes to add Relyvrio to the two older FDA-approved medications she already takes for the disease.

 

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