The drug from Amylyx Pharmaceuticals has become a rallying cause for patients with the deadly neurodegenerative disease ALS, their families and members of Congress who’ve joined in pushing the FDA to greenlight the 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 and says the chemicals help protect cells from early death.
After further discussions, Amylyx decided to submit its pill for approval based on survival data gathered after its initial study. The company said that showed patients who took the drug lived about six months longer than those taking a dummy pill. Currently, there are only two FDA-approved drugs for ALS, the more effective of which extends life by several months.
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