The medical community has not been entirely convinced of the U.S. FDA’s decision to approve Biogen Inc’s (NASDAQ: BIIB) Aduhelm drug to treat Alzheimer’s last month.
Some health insurers also declined coverage for Aduhelm
The latest blow to the biotech firm came late on Thursday when Providence, Mount Sinai Health System, and the Cleveland Clinic refused to administer the drug on concerns about its effectiveness for patients. The news comes shortly after some health insurers declined to cover for the therapy as well.
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More importantly, the drug is also under review on a federal level to determine if Medicare – the federal insurance programme that shields the majority of Alzheimer’s patients – should cover Aduhelm, and if so, under what terms and conditions.
Right after the agency’s approval for Aduhelm in early June, Alzheimer’s specialist Dr Jason Karlawish warned in an interview with CNBC that “another study is needed to establish whether this drug, in fact, is effective.”
Studies on Aduhelm as a treatment of Alzheimer’s showed it to be only moderately effective. Its side effects, on the other hand, were more serious, including brain bleeding – making critics question if the risk to reward ratio was favourable enough for FDA’s green signal.
Federal investigation launched into Aduhelm’s FDA approval
Last week, FDA Acting Commissioner Dr Janet Woodcock requested a federal investigation into the interaction between Biogen representatives and the FDA staff prior to the drug’s approval. Responding to the news on Thursday, Biogen spokeswoman said:
“Medical decisions should be based on science and data. So, it is disappointing that patients living with Alzheimer’s may reportedly not be able to access Aduhelm at some facilities. Biogen continues to stand 100% behind Aduhelm and the clinical data that supported approval.”
Biogen shares opened about 1% down on Friday morning. The $48 billion company has a price to earnings ratio of 16.99.
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