The biggest question in biotech — other than whether Covid-19 vaccines will work — centers on Biogen and its yearslong quest to win Food and Drug Administration approval for a polarizing treatment for Alzheimer’s disease.
Last week set the stage for the debate ahead. First, the FDA’s internal clinical review team argued that Biogen’s mixed bag of supporting data was strong enough to justify approving the drug, called aducanumab. Then, a panel of independent experts reviewed the same data and came to a starkly opposite conclusion, with 10 of 11 panelists voting that Biogen hadn’t adequately proved aducanumab’s efficacy.
The overwhelmingly negative outcome of that meeting puts the FDA in a real bind. Approving aducanumab means ignoring the strong recommendation of its own outside advisers and perhaps damaging the agency’s credibility as an independent regulator. But rejecting the drug — or asking Biogen to conduct another clinical trial — means disappointing Alzheimer’s patients and their families.
