Editor’s Corner—The FDA’s decision on aducanumab will drag down innovation for years to come | FierceBiotech
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The amyloid theory just won’t die. In fact, by approving Biogen’s new Alzheimer’s disease drug, the FDA has just resurrected it for a long and healthy future.
This is great news for Biogen, but it will decimate Alzheimer’s research, faith in the agency and the healthcare budget for decades to come.
In an approval based on amyloid clearance, the FDA gave Biogen the benefit of the doubt in allowing it to market aducanumab, now Aduhelm, in Alzheimer’s, saying it doesn’t need actual proof that it can help patients for many, many years.
Instead, the FDA said a surrogate endpoint, which substitutes a biomarker that might indicate efficacy for an actual clinical endpoint that demonstrates it directly, was good enough for a drug that could make Biogen $17 billion a year.
