FDA Releases Fresh Details on Internal Debate Over Controversial Alzheimer's Drug

By Laurie McGinley

Amid swirling controversy over its recent approval of Biogen's Aduhelm, the Food and Drug Administration (FDA) is providing additional insight on why it gave the Alzheimer's drug the green light against an advisory committee's recommendation. Aduhelm was greatly anticipated for its promise to slow cognitive decline in patients, but the evidence did not clearly demonstrate efficacy. The drug targets amyloid beta plaque in the brain that is believed to damage and kill brain cells, but whether reducing the sticky substance actually helps patients remains unclear. While that uncertainty kept FDA from granting the monthly injectable full clearance, it agreed to "accelerated approval" on the grounds that the treatment was "reasonably likely" to be effective. Despite support from the patient community and advocates, some scientists said even conditional approval is inappropriate when the science does not support it. The decision to move forward with approval prompted three members of the advisory board to vacate their positions. According to one of them, Harvard Medical School professor Aaron Kesselheim, Aduhelm represents "the worst drug approval decision" in recent history.

Read the full article from Washington Post here.