The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease.
FILE - This Aug. 2, 2018 file photo shows the U.S. Food and Drug Administration building behind FDA logos at a bus stop on the agency's campus in Silver Spring, Md. The Food and Drug Administration has issued a negative review of a closely watched experimental drug for the debilitating illness known as Lou Gehrigs disease. The review comes ahead of a meeting this week for outside experts to vote on the drug for ALS.
ALS, or amyotrophic lateral sclerosis, destroys nerve cells needed to walk, talk, swallow and — eventually — breathe. There is no cure and most people die within three to five years. After further discussions with regulators last summer, Amylyx decided to submit its drug for approval based on the initial study plus survival data gathered afterwards. The company said that data showed patients who took the drug lived about six months longer than those taking a dummy drug.
. Three panel members resigned over the controversial decision and congressional investigators launched a probe into FDA’s handling of the drug’s review. As in the current case, the FDA faced intense pressure from patient groups to grant approval.Currently, there are only two FDA-approved drugs for ALS, the more effective of which extends life by several months.
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