FDA Advises Enhanced Monitoring for Alzheimer's Patients on Biogen's Leqembi

The FDA recommends increased monitoring of patients with Alzheimer's disease who are taking Biogen's drug Leqembi. The recommendation is based on data showing an increased risk of bleeding in patients who have received the drug. Biogen is a leading manufacturer of therapeutic products, with a significant portion of its net sales coming from the sales of medicines and royalties.

The U.S. Food and Drug Administration (FDA) has issued a recommendation for increased monitoring of patients with Alzheimer's disease who are taking Biogen's drug Leqembi. The recommendation is based on data showing an increased risk of bleeding in patients who have received the drug. This latest development underscores the importance of vigilant patient monitoring for novel therapies targeting complex diseases like Alzheimer's.

Leqembi, an anti-amyloid beta monoclonal antibody developed by Eisai and Biogen, received European Commission approval in April 2025 as the first therapy targeting an underlying cause of Alzheimer’s disease. The drug has demonstrated a 31% reduction in clinical decline compared to placebo over 18 months in clinical trials [1]. However, the FDA's recommendation highlights potential safety concerns, including infusion-related reactions and ARIA events, which have been reported in clinical trials [1].

The FDA's advisory emphasizes the need for healthcare providers to be aware of these potential side effects and to monitor patients closely. The recommendation comes as Biogen continues to expand the availability of Leqembi in Europe, with launches in Austria and Germany scheduled for August 2025 [1].

Biogen, a leading manufacturer of therapeutic products, has a significant portion of its net sales coming from the sales of medicines and royalties. The company's stock, represented by the ticker symbol BIIB, has seen increased trading activity among congressional members and institutional investors in recent months. In the past six months, members of Congress have traded BIIB stock three times, with two purchases and one sale, indicating interest in the company's financial performance and prospects [2].

The FDA's recommendation underscores the importance of balancing the potential benefits of new treatments with the need for rigorous safety monitoring. As Leqembi continues to gain approvals and expand its market reach, the company and healthcare providers will need to work together to ensure that patients receive the most effective and safest care possible.

References:
[1] https://www.quiverquant.com/news/Eisai+and+Biogen+Launch+LEQEMBI%C2%AE+in+Austria+and+Germany+as+First+Alzheimer%E2%80%99s+Disease+Therapy+Approved+in+Europe+Targeting+Amyloid+Beta
[2] https://www.quiverquant.com/news/$BIIB+Congressional+Stock+Trading