In a bid to “reprioritize” its resources for treating Alzheimer’s disease, drug maker Biogen announced that it will end its licensing agreement to produce the drug, Aduhelm, and shut down its related clinical study.
Instead, Biogen plans to redouble its efforts in developing Leqembi (lecanemab-irmb), “the first anti-amyloid beta treatment with FDA traditional approval in the United States, and will accelerate development of potential new treatment modalities, including its ASO targeting tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).”
“As a pioneer in Alzheimer’s disease, Biogen is reprioritizing resources to build a leading franchise to address the multiple pathologies of the disease and patient needs,” Biogen President and CEO Christopher A. Viehbacher declared in a press release. “We plan to further advance the launch of Leqembi, together with Eisai, and continue to bolster innovation with the development of the other assets in our pipeline. When searching for new medicines, one breakthrough can be the foundation that triggers future medicines to be developed. Aduhelm was that groundbreaking discovery that paved the way for a new class of drugs and reinvigorated investments in the field.”
Biogen’s Troubled Launch
The company touted Aduhelm, a monoclonal antibody that targets the build-up of the protein amyloid beta in brain tissue, as a next-generation Alzheimer’s treatment. But it ran into trouble before it ever hit the market.
The company shut down human trials early because of mixed results before the FDA signed off on the drug – provisionally – in 2021. It marked the first new FDA-approved treatment in more than a decade. Nevertheless, outside advisors to the FDA argued against its approval, charging that it didn’t prove as effective as its developer claimed.
In fact, Medicare refused to cover the cost of the drug unless the patient was enrolled in a clinical trial. That decision made Aduhelm’s high price tag – roughly $56,000 annually – even more problematic. That price – and the cost of producing the drug – contributed to its cancellation since the company couldn’t find a partner to help it better manage its costs.
“We see the re-prioritization of Aduhelm resources to the Leqembi launch as a positive that reflects the true priorities of the company going forward,” BMO Capital Markets analyst Evan Seigerman told Reuters.
Other Available Treatments
Support groups, such as the Alzheimer’s Association, lamented the loss of the drug but also pointed to other available treatments.
“Approval of Aduhelm was a landmark event for the Alzheimer’s field and, most importantly, provided hope for the millions of people living with early Alzheimer’s, and their families,” the group said in a press release. “It was the first FDA-approved treatment to address one of the underlying causes of the disease, not just the symptoms. And the field has continued to advance.”
The nonprofit highlighted other options, such as:
- Biogen’s Leqembi, is an FDA-approved drug that is already available. Medicare covers the cost of the drug if the prescribing physician is part of a CMS-approved registry.
- Donanemab, an Eli Lilly treatment, is under FDA review after wrapping its Phase 3 trial. Many expect the FDA to approve the drug later this year.
Further Reading
Facilitating Treatment Initiation in Early-Stage Alzheimer Disease
Treatment of Early-Stage Alzheimer Disease
Researchers Uncover Alzheimer’s Link to Past Medical Treatments
