#USA #Stockholm #Leqembi #BioArctic #Alzheimer's

FDA Approves IV Maintenance Dosing of Leqembi®

In a significant advancement for Alzheimer's disease treatment, the U.S. Food and Drug Administration (FDA) has sanctioned the intravenous (IV) maintenance dosing of Leqembi® (lecanemab-irmb). This approval, announced by BioArctic AB, pertains to a dosing schedule for patients diagnosed with early Alzheimer's disease who finished an initial biweekly treatment phase.

Details of the Approval

The FDA's decision allows patients who have completed 18 months of bi-weekly treatment to shift to a once every four weeks 10 mg/kg dosing regimen. This transition aims to ensure that patients receive ongoing beneficial effects from the treatment while simplifying the administration process. The urgency for such a treatment plan arises from the continuous neurotoxic nature of Alzheimer's, necessitating sustained intervention.

Data supporting this decision comes from studies revealing that halting treatment leads to a resurgence of brain amyloid and a deterioration in clinical conditions. Observations indicate that patients treated with Leqembi for three years showed superior cognitive stability compared to a matched control group, highlighting its potential to meaningfully enhance patient quality of life.

Mechanism of Action

Leqembi functions by targeting amyloid-beta (Aβ) plaques in the brain, thus clearing neurotoxic species known to contribute to the disease's progression. Unlike other treatments, which may solely aim at plaque removal, Leqembi additionally undertakes the continuous elimination of highly toxic protofibrils that inflict neuronal injury. This dual action is crucial, as Alzheimer's causes chronic neurotoxic processes that extend beyond simple plaque buildup.

The data presented by Eisai and BioArctic indicates that the transition to a less frequent dosing schedule is expected to preserve the clinically relevant benefits observed during the initial treatment phase. The modeling data derived from both the Phase 2 studies and the Clarity AD study reinforces this expectation.

Global Context and Future Outlook

Leqembi already enjoys approval in several international markets, including Japan, China, and the UK. The recent nod from the FDA complements positive recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), signaling a growing recognition of Leqembi's therapeutic potential globally.

Additionally, Eisai has sought approvals in 17 other territories and continues to explore new formulations, including a subcutaneous autoinjector designed for weekly dosing, further increasing accessibility for patients.

The collaboration between BioArctic and Eisai, which dates back to 2005, underscores their commitment to finding innovative solutions for neurodegenerative diseases. BioArctic claims joint commercialization rights in the Nordic region and is poised for a comprehensive launch there pending final European approvals.

Conclusion

The FDA's endorsement for Leqembi's IV maintenance dosing marks a pivotal moment in the fight against Alzheimer's disease. As research progresses and more data become available, there's hope for improved patient outcomes and a more structured treatment pathway for those grappling with early-stage Alzheimer's.

BioArctic aims to further expand its research scope, tackling not only Alzheimer's but also other neurodegenerative conditions, reinforcing their position as a leader in biopharmaceutical innovation.

For more detailed prescribing information regarding Leqembi®, including potential side effects, please visit the official bioarctic website.