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Biogen Admits To "Slower Than Anticipated" Launch Of Its Alzheimer's Drug

Biotech giant Biogen Inc. (BIIB) on Thursday admitted that the launch of its controversial Alzheimer's drug Aduhelm "was slower than we initially anticipated."

According to health-oriented news website Stat News, Biogen CEO Michel Vounatsos blamed "confusion, misinformation and controversy" surrounding the drug's accelerated approval for slow sales.

"Although we are facing some near-term challenges and everybody can see that, we continue to see a very high level of physician and patient interest and we continue to believe the mid- to long-term opportunity remains significant," he added.

Only about 50 centers around the country have administered at least one dose of Aduhelm, Biogen said at an investor conference sponsored by the investment bank Morgan Stanley. This has forced the company to revisit its "already very low sales target" for 2021.

Aduhelm has been surrounded by controversies since the U.S. FDA approved it for the treatment for Alzheimer's in June. It was the first drug to be approved in 18 years for the disease.

FDA's gave its approval despite objections from 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 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.

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