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Decision on Drug with Complex History Expected

The US Food and Drug Administration is to soon decide whether to approve a monoclonal antibody therapy to slow cognitive decline among Alzheimer's disease patients, the Washington Post reports.

The drug, aducanumab, has a complicated history, the Post notes. In initial studies, it appeared to decrease the amount of amyloid protein that accumulates in patients' brains and limit cognitive decline, but the drug's maker, Biogen, shelved it when clinical trials suggested it was not as helpful as expected. But it then resurrected the drug after further analysis and decided to seek FDA approval, as Time magazine reported at the time.

Last November, FDA regulators appeared to support the drug's approval, but an outside advisory panel did not. NPR reported then that the panel was concerned about the contradictory trial reports and what it viewed as pressure to focus on the positive results.

Critics tell the Post that Biogen should run a third trial of the drug prior to approval. "When you have one study that is positive and one that is negative, it seems to lead to an inability to draw a conclusion and therefore to a need for a third trial," the Mayo Clinic's David Knopman, a member of the FDA advisory committee, but who was not part of the discussion since he was a site investigator for aducanumab, tells the Post.

Advocates argue that another trial will take too long, the Post says, and that the drug could help a portion of patients now.

The FDA is to make is decision by Monday, it adds.