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.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
Royal Caribbean Group's ultra-luxury brand Silversea Cruises is set to launch the world's first hybrid-powered cruise ship in the summer of 2023. This will also be the first ship with large-scale fuel cell technology to enable emission-free port operations. The fuel cells will provide 100% of power while at port. Affco USA is recalling around 24,461 pounds of frozen raw lamb shoulder products that were not presented for import re-inspection into the U.S., the U.S. Department of Agriculture's Food Safety and Inspection Service or FSIS announced. The recall involves the frozen raw lamb shoulder items that were imported on July 12, 2021. American Express Company (AXP) reported an increase in profit for the third quarter that also topped Wall Street estimates. Consolidated total revenues net of interest expense rose 25 percent year-on-year, primarily reflecting growth in Card Member spending, as well as a rise in the average discount...
Follow RTT