The Food and Drug Administration’s approval of Biogen’s Alzheimer’s drug Aduhelm in early June has become one of the most controversial and publicly acrimonious decisions in the agency’s recent history. In the nearly four months since, the decision has led to high-profile resignations by FDA advisers, a federal investigation and extraordinary pushback from a number of insurers and physicians.
Late on Monday evening, Japanese drugmaker Eisai, Biogen’s partner in Alzheimer’s research, revealed it had begun the process of asking the FDA for accelerated approval of a second drug that works similarly to Aduhelm.
