FDA skeptical of benefits from experimental ALS drug

WASHINGTON — Federal health regulators issued a negative review Monday of a closely watched experimental drug for the debilitating illness known as Lou Gehrig’s disease, after months of lobbying by patient advocates urging approval.

The meeting is being closely watched as an indicator of the FDA’s approach to experimental drugs with imperfect data and its ability to withstand outside pressure. Amylyx’s drug is a combination of two older drugs: a prescription medication for liver disorders and a dietary supplement associated with traditional Chinese medicine. Amylyx has patented the combination in a powder and says the chemicals help protect cells from early death.

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. Currently, there are only two FDA-approved drugs for ALS, the more effective of which extends life by several months.

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