Biogen's Leqembi Shows Promise in Presymptomatic Alzheimer's, But Challenges Remain

Biogen and its partner Eisai are making strides in expanding the reach of their anti-amyloid Alzheimer's drug Leqembi, with promising developments in presymptomatic treatment and new formulations. However, the pharmaceutical giant faces hurdles in convincing doctors to adopt this paradigm-shifting approach to Alzheimer's care.

Leqembi's Growth and New Frontiers

Leqembi, approved in 2023 for symptomatic Alzheimer's patients, has shown steady growth with $121 million in sales for the third quarter, representing an 82% increase. U.S. sales accounted for $69 million of this total. Despite this progress, Biogen is pushing to broaden Leqembi's application to presymptomatic patients through the AHEAD 3-45 study, mirroring Eli Lilly's efforts with their drug Kisunla in the TRAILBLAZER-ALZ-3 trial.

Biogen CEO Chris Viehbacher highlighted the recent launch of Leqembi IQLIK, a subcutaneous formulation designed to ease the treatment burden. "A lot of what we've been doing is trying to make the care pathway simpler for physicians with the idea of being able to increase throughput," Viehbacher stated during the company's third-quarter earnings call.

Advancements in Diagnosis and Treatment Accessibility

The introduction of blood-based biomarker tests by companies like Roche and Lilly is set to revolutionize Alzheimer's diagnosis. The Elecsys pTau181 test, designed for use in primary care settings, can help rule out Alzheimer's and identify patients requiring further evaluation. This development, coupled with the new subcutaneous Leqembi formulation, is expected to significantly reduce the workload at neurology clinics and improve treatment accessibility.

Alicia Alaimo, President and Head of North America commercial operations for Biogen, noted the swift uptake of these new diagnostic tools. She also highlighted an ongoing challenge: "Right now, about half of the patients who get into see a neurologist are not actually eligible for treatment." Improved triaging is expected to enhance treatment uptake for Leqembi.

Challenges and Future Outlook

As the focus shifts towards presymptomatic patients, Biogen faces the challenge of convincing doctors to look for signs of Alzheimer's even earlier. The company is not alone in promoting early Alzheimer's treatment, with competitors like Eli Lilly driving physician awareness of new therapies and diagnostic tests.

Alaimo emphasized the importance of commercial payers in this evolving landscape, particularly for younger, presymptomatic patients who may not be covered by Medicare. "Clearly some of those conversations have already happened, because we do have some younger population patients that want to go on product," Alaimo said. She expressed optimism about improved treatment capacity by the time presymptomatic trial results are available.

As Biogen continues to navigate the complex Alzheimer's treatment landscape, the company remains focused on simplifying care pathways, improving diagnosis, and expanding access to potentially game-changing therapies like Leqembi.