Biogen Withdraws European Marketing Application for New Alzheimer's Drug Aduhelm

On April 22, Biogen announced that it had notified the European Medicines Agency (EMA) of its decision to withdraw the Marketing Authorization Application (MAA) of its new drug Aduhelm (aducanumab) for the treatment of early Alzheimer's disease. In communicating with the EMA's Committee for Medicinal Products for Human Use (CHMP), the agency pointed out that the data provided so far were insufficient to support the EMA's positive opinion on the marketing authorization of aducanumab (see: EU CHMP rejects recommendation for approval of the new AD drug Aduhelm).

On June 7, 2021, the US FDA resolutely approved the marketing of Aduhelm based on the clinical surrogate endpoint (the level of amyloid plaques in the patient's brain) despite the objections of the expert committee. This led to the resignation of three committee members. After the listing, the market has also been controversial about this drug. On the one hand, Biogen announced in early July that the use of Aduhelm should be limited to AD patients with mild symptoms. The rollout didn't go well, and the company halved its pricing from the original $56,000, and even so, total revenue in 2021 is only $3 million.

Faced with a dismal post-IPO market performance, Biogen laid off multiple employees to save up to $750 million in the Aduhelm controversy. In addition, Biogen blamed part of the failure of Aduhelm on the company's chief research and development officer, Alfred Sandrock, who has left the company at the end of 2021. It is understood that Sandrock has accepted the invitation of Voyager Therapeutics to become the company's CEO.

Meanwhile, the Centers for Medicare and Medicaid Services (CMS) this month confirmed a highly restrictive coverage plan for the drug, limiting coverage for Aduhelm and other similar drugs to patients in certain clinical trials.

In March this year, Biogen entered into a new commercial arrangement for Aduhelm with its partner Eisai, Eisai withdraws from the market, and Biogen has the sole decision on the development, commercialization and production of Aduhelm as of March 14, 2022 right. In 2022, the two parties will continue to have a global profit and loss sharing arrangement, subject to Eisai's 2022 fee cap. Effective January 1, 2023, Eisai will be entitled to tiered royalties on net sales of Aduhelm.

Now, Biogen needs to rethink one thing, and as RBC Capital Markets' Brian Abrahams suggested earlier this month, it should consider halting the commercialization of Aduhelm.

Eisai and Biogen's second anti-beta-amyloid antibody, lecanemab, may perform even better, with late-stage trial results expected in the second half of 2022.