A much-debated drug for Lou Gehrig's disease won U.S. approval, 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.
One outside group that analyzes the cost effectiveness of new treatments pegged the drug’s value at between between $9,100 and $30,700 per year. The Institute for Clinical and Economic Review also noted that many patients are expected to take Amylyx’s drug in combination with an older therapy, which costs over $170,000 per year.
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