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

Biogen and its partner Eisai are making significant strides in the fight against Alzheimer's disease, with their anti-amyloid drug Leqembi showing potential for presymptomatic patients. However, the pharmaceutical giant faces hurdles in convincing doctors to adopt this paradigm-shifting approach to Alzheimer's treatment.

Leqembi's Performance and Market Challenges

Leqembi, approved in 2023 as a disease-modifying anti-amyloid beta therapy, has shown steady growth but faces adoption challenges. In the third quarter, Leqembi generated $121 million in sales, representing an 82% increase, with U.S. sales accounting for $69 million. Despite this growth, uptake has been slower than anticipated as physicians grapple with the new treatment paradigm.

Biogen CEO Chris Viehbacher acknowledged the difficulties, stating, "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." To address these challenges, Biogen has introduced a subcutaneous version of the drug, Leqembi IQLIK, which launched this month for the existing symptomatic indication.

Expanding to Presymptomatic Patients

Biogen is not alone in its pursuit of treating presymptomatic Alzheimer's patients. Both Biogen and Eli Lilly are conducting clinical trials to demonstrate the efficacy of their respective drugs in slowing disease progression before symptoms appear. Biogen's AHEAD 3-45 study with Leqembi and Lilly's TRAILBLAZER-ALZ-3 study with Kisunla are at the forefront of this research.

The potential expansion to presymptomatic patients represents a significant shift in Alzheimer's treatment. However, it also raises questions about how to convince doctors to start looking for signs of the disease even earlier, given the current challenges in treating symptomatic patients.

Innovations in Diagnosis and Treatment

Recent advancements in diagnostic tools are expected to facilitate earlier detection and treatment of Alzheimer's. Roche and Lilly have introduced a blood-based biomarker test, the Elecsys pTau181, which can help rule out Alzheimer's and identify patients requiring further evaluation. This test is designed for use in primary care settings, potentially streamlining the referral process to neurologists.

Alicia Alaimo, President and Head of North America Commercial Operations for Biogen, noted the swift uptake of these new biomarker tests. She also highlighted that about half of the patients who currently see a neurologist are not eligible for treatment, suggesting that improved triaging could significantly increase treatment uptake for Leqembi.

As the pharmaceutical industry continues to evolve its approach to Alzheimer's treatment, the coming months and years will be crucial in determining the success of these new strategies and their impact on patients' lives.