Biogen admits its Alzheimer’s drug is being rolled out “slower than anticipated”

(RTTNews) – Biotech giant Biogen Inc. (BIIB) admitted Thursday that the launch of its controversial Alzheimer’s drug Aduhelm was “slower than we originally expected.”

According to health news website Stat News, Biogen CEO Michel Vounatsos blamed “confusion, misinformation and controversy” about the drug’s accelerated approval for slow sales.

“While we are facing some short-term challenges that everyone can see, we continue to see a very high level of interest from doctors and patients and continue to believe that the medium to long-term opportunity remains great,” he added.

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

Aduhelm has been surrounded by controversy since the US FDA approved it for the treatment of Alzheimer’s in June. It was the first drug approved for the disease in 18 years.

The FDA granted its approval despite objections from its Advisory Committee on Drugs for Peripheral and Central Nervous Systems.

Last November, the 11-member committee voted almost unanimously that the drug should not be approved. The panel voted 0 yes, 10 no and 1 unsure that it is “reasonable” to view the single positive Phase III study as primary evidence of aducanumab’s effectiveness in treating Alzheimer’s disease.

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

Alzheimer’s drug development has been plagued by a high rate of failure. In March 2019, Biogen and Eisai abandoned their global late-stage studies based on the results of a futility analysis, which indicated that the studies were unlikely to meet their primary endpoint once completed.

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