FDA Calls For Investigation Into Approval Of Biogen's Alzheimer's Drug

The U.S. Food and Drug Administration has called for an investigation on the recent approval of Biogen Inc.'s (BIIB) Alzheimer's drug, Aduhelm.

Acting FDA Commissioner Dr. Janet Woodcock has asked the Office of the Inspector General to investigate interactions between the U.S. agency and Biogen representatives prior to the drug's approval on June 7.

"Given the ongoing interest and questions, today I requested that @OIGatHHS conduct an independent review and assessment of interactions between representatives of Biogen and FDA during the process that led to the approval of Aduhelm," Woodcock tweeted.

In June, the FDA approved Aduhelm for the treatment for Alzheimer's, thus becoming the first drug to be approved in 18 years for the disease.

However, FDA's decision created controversy as the approval was given despite objections of its advisory Peripheral and Central Nervous System Drugs Advisory Committee.

Last November, the 11-member committee voted nearly in unison that the drug should not to be approved. The panel voted 0 yes, 10 no and 1 uncertain that it is "reasonable" to consider the single phase III positive study, as primary evidence of effectiveness of Aducanumab for the treatment of Alzheimer's disease.

At least three members of the panel have resigned in protest of the agency's decision.

The development of the Alzheimer's drugs was plagued by high failure rate. In March 2019, Biogen and Eisai had discontinued their global late-stage trials based on results of a futility analysis, which indicated the trials were unlikely to meet their primary endpoint upon completion.

"I believe that it is critical that the events at issue be reviewed by an independent body such as the Office of the Inspector General in order to determine whether any interactions that occurred between Biogen and FDA review staff were inconsistent with FDA policies and procedures," Woodcock wrote in a letter sent Friday.

"Furthermore, I have tremendous confidence in the integrity of the staff and leadership of the Center for Drug Evaluation and Research involved in the aducanumab review and their commitment to unbiased and science-based decision-making," she added.

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