A closely watched experimental drug for Lou Gehrig’s disease got an unusual second look from U.S. regulators on Wednesday, following intense pressure to approve the treatment for those with the fatal illness.
Patients and their families have rallied behind the drug from Amylyx Pharma, launching an aggressive lobbying campaign and enlisting members of Congress to push the Food and Drug Administration to grant approval.
The FDA has approved only two therapies for the disease, amyotrophic lateral sclerosis, which destroys nerve cells needed for basic functions like walking, talking and swallowing. The more effective of the two drugs extends life by several months.
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