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Biogen, the drug company, said on Tuesday that it would ask the Food and Drug Administration to approve an experimental drug, aducanumab, to treat people with mild cognitive impairment and the earliest signs of Alzheimer’s disease. About 10 million Americans might qualify for treatment if the drug were approved, according to Michel Vounatsos, the company’s chief executive. Even so, it is not quite time for these patients to celebrate. (Kolata, 10/22)

Biogen’s aducanumab was the last great hope for treating Alzheimer’s disease through an approach that the leading lights in the field have believed in for 30 years: siccing a lab-made monoclonal antibody on amyloid plaques in the brain. Now that aducanumab is back from the dead, with the company announcing on Tuesday that additional data overturned its earlier conclusion that the drug had no chance of working, the “amyloid hypothesis” also has a new lease on life — and Biogen has a potentially zillion-dollar moneymaker, should the Food and Drug Administration be persuaded. (Begley, 10/23)

Beyond the grabby headlines, punchy tweets, and stock market bounces, Biogen’s surprise resuscitation of a once-doomed treatment for Alzheimer’s disease drew a hefty dose of caution — and even some skepticism. The basis for Biogen’s decision was a re-analysis of data from late-stage studies of its drug, aducanumab. Those data, the company said, showed the treatment reduced the rate of patients’ cognitive decline. (Begley and Garde, 10/23)

With a data picture this cloudy, it isn’t hard to imagine the FDA asking for another late-stage efficacy study before any approval. That would likely push any possible approval back by years, quelling today’s optimism. What’s more, even if regulators sign off, insurance companies will likely need to be persuaded that the drug can slow disease progression before they pay for it. (Grant, 10/22)