As US launch falters, Biogen ditches Aduhelm application in Europe

Biogen’s aducanumab, already hamstrung in the U.S. by a stifling coverage decision, won’t be hitting the European market anytime soon.  

Biogen has scrapped its filing for the Alzheimer’s disease drug in the European Union after talks with regulators made it clear the data provided so far are unlikely to support marketing approval, the company said Friday.

Aducanumab, also known as Aduhelm, has been mired in controversy over its data and pricing ever since it won its U.S. green light last summer. Meanwhile, the Centers for Medicare & Medicaid Services (CMS) this month confirmed a highly restrictive coverage plan for the drug, which limits the use of Aduhelm and other meds like it to patients in certain clinical trials.

Whether the antibody keeps hold of its accelerated approval in the U.S. “may be contingent upon verification of clinical benefit in confirmatory trial(s),” Biogen noted in a release.

In announcing its EU application withdrawal, Biogen reaffirmed its commitment to Alzheimer’s R&D and patient advocacy, plus its partnership with Japanese pharma Eisai.

The partners in March hashed out a new commercial arrangement for Aduhelm, with Eisai bowing out of marketing and Biogen taking over “sole decision making and commercialization rights” on the drug. Starting next year, Eisai will exit its Aduhelm support role and ditch its cut in profits or losses. Instead, Eisai will be in line for a tiered royalty based on Aduhelm sales, the companies said last month.

Whether that royalty amounts to much is unclear. Aduhelm generated just $1 million in 2021’s fourth quarter and $3 million for all of 2021.

Still, all is not lost for the beleaguered anti-amyloid drug, RBC Capital Markets analysts wrote in a note to clients last month. The drug still has a slim shot at billions of dollars in sales thanks to a significant community of patients and doctors banking on its use. A survey conducted by the RBC team, which polled 88 physicians, showed a strong market remains for Aduhelm or other beta-amyloid antibodies.

Still, part of the med’s potential upswing would have hinged on less restrictive coverage by CMS, the analysts said at the time. With the agency sticking to its guns on Aduhelm access, sales prospects for the med look increasingly bleak.

Now, Biogen has some serious re-thinking to do and—as RBC Capital Markets’ Brian Abrahams suggested earlier this month—ought to consider ceasing Aduhelm commercialization.

Eisai and Biogen could fare better with a second anti-beta-amyloid antibody lecanemab, which is expected to post late-stage trial results in the back half of 2022.