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Food and Drug Administration (FDA) drew criticisms after granting Alzheimer’s disease drug Aduhelm a conditional approval. It allows the drug scientifically known as aducanumab to be prescribed and used while its maker Biogen conducts a post-marketing, phase 4 confirmatory study that could take years to complete. Aduhelm is the first Alzheimer’s medication approved by the FDA since 2003. According to the influential Institute for Clinical and Economic Review (ICER), the FDA “has failed in its responsibility to protect patients and families from unproven treatments with known harms” in approving Aduhelm. ICER questions Aduhelm’s effectiveness The FDA, which announced the approval on June 7, said that the drug was the first to treat the underlying mechanism in Alzheimer’s. But ICER didn’t see it that way. ....
New Alzheimer’s drug Aducanumab – cost, side effects, timeline and other questions answered Patients and their families are starting to inquire about the new Alzheimer’s drug approved this week by the US Food and Drug Administration. Shipments of the medication are expected to go out in just a couple of weeks. Hospitals are on tap to administer treatment when needed. And there is serious division in the FDA, especially around the drug’s effectiveness. Aducanumab, to be sold under the brand name Aduhelm, was approved to treat patients with Alzheimer’s disease against the recommendation of an FDA advisory committee that concluded last year there is not enough evidence to support approval of the treatment. The FDA has not approved a novel therapy for Alzheimer’s disease since 2003. ....
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New Alzheimer’s drug aducanumab: cost, side effects, timeline and other questions answered Patients and their families are starting to inquire about the new Alzheimer’s drug approved this week by the US Food and Drug Administration. Shipments of the medication are expected to go out in just a couple of weeks. Hospitals are on tap to administer treatment when needed. And there is serious division in the FDA, especially around the drug’s effectiveness. Aducanumab, to be sold under the brand name Aduhelm, was approved to treat patients with Alzheimer’s disease against the recommendation of an FDA advisory committee that concluded last year there is not enough evidence to support approval of the treatment. The FDA has not approved a novel therapy for Alzheimer’s disease since 2003. ....