Pharma

2/13/2024, 10:12 PM

Biogen exits: Controversial Alzheimer's drug Aduhelm to be discontinued

Biotech Company Sets Focus: New Alzheimer's Drug Being Advanced, Further Developments Under Consideration.

The biotechnology company Biogen has announced its focus on expanding its portfolio of Alzheimer's drugs and discontinuing the development of Aduhelm. Additionally, the company plans to cancel a postmarketing study for full approval in the USA.

The Aduhelm saga comes to an end for Biogen, characterized by critical examination of the approval process and the high sales price of the drug. The company from Cambridge, Massachusetts, also announced that it will continue to advance Leqembi, the already approved Alzheimer's drug developed in collaboration with partner Eisai.

Additionally, the development of potential new Alzheimer's treatments is to be accelerated.

Biogen CEO Christopher Viehbacher stated: "In the search for new drugs, a breakthrough can be the foundation for the development of future medications. Aduhelm was this groundbreaking discovery that paved the way for a new class of drugs and revived investments in this area."

Approximately six million people in the USA suffer from Alzheimer's, a progressive, degenerative brain disease that affects memory and cognitive abilities. Aduhelm was for a long time one of the most closely watched Alzheimer's drugs in development.

Doctors, patients, and their families hoped it would slow the progression of the disease, while investors anticipated revenues in the billions. The FDA's approval of the monthly infusion drug with the active ingredient Aducanumab in June 2021 was the first approval of an Alzheimer's drug in nearly two decades.

But many doctors and even some of the US government's own expert advisors questioned the effectiveness of the drug.

Biogen Priced Aduhelm at $56,000 per Year per Patient. Medicare, the Government Health Insurance, Refused to Cover the Drug. Doubts, the High Price, and Limited Insurance Coverage Reduced Aduhelm's Reach to Many Patients.

The sales figures were sobering. The former CEO of Biogen, Michel Vounatsos, and the head of research, who had accompanied the development of the drug, left the company, and it effectively halted the marketing of the drug.

A December 2022 investigation by the Democrats in the House of Representatives concluded that the FDA had collaborated inappropriately with Biogen representatives prior to the drug's approval.

No Separate Figures for Aduhelm Published in Biogen's Current Annual Report. Analysts stated that Biogen's decision was largely anticipated. Last year, Biogen started seeking potential partners or external financing for Aduhelm, but without success.

The costs for the shutdown of the program amount to 60 million US dollars. Biogen will return the rights to the drug to Neurimmune, a biotechnology company based in Switzerland.

Biogen also announced that it will invest a significant portion of the resources freed up by the discontinuation of Aduhelm into the Alzheimer's franchise, which will be supported by Leqembi as a cornerstone. Eisai said the drug could generate a revenue of 7 billion US dollars globally by 2030.

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