Controversy surrounding Biogen’s newly approved Alzheimer’s drug costs FDA one more panelist

USA – A third member of a key Food and Drug Administration advisory panel has resigned over the agency’s controversial decision to approve Biogen’s new Alzheimer’s drug, Aduhelm. Dr. Aaron Kesselheim, a professor of medicine at Harvard Medical School, said in his resignation letter that the agency’s decision on Biogen is probably the worst drug approval decision in recent U.S. history. “At the last minute, the agency switched its review to the Accelerated Approval pathway based on the debatable premise that the drug’s effect on brain amyloid was likely to…

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FDA grants approval for ADUHELM as the first and only Alzheimer’s disease treatment

USA – U.S. Food and Drug Administration has approved Biogens’ Aduhelm (aducanumab) for the treatment of Alzheimer’s, a debilitating disease affecting 6.2 million Americans, the first new treatment approved for Alzheimer’s since 2003. Aduhelm has been approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Currently available therapies only treat symptoms of the disease whereas this treatment option is the first therapy to target and affect the underlying disease process of…

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