The U.S. Food and Drug Administration (FDA)’s accelerated approval of ADUHELM™ (aducanumab) for the treatment of early Alzheimer’s disease in 2021 met with controversy, and uptake was curtailed by a lack of clinician support and Medicare coverage. Now, supported by landmark clinical data from a phase 3 trial, next-in-class anti-Aβ monoclonal antibody (MAb) lecanemab has been granted accelerated approval by FDA and appears poised for ex-U.S. launches, marketed under the brand name LEQEMBI™. Donanemab, and others in the class (e.g., Roche’s gantenerumab), may follow suit pending the results of ongoing trials. If approved, differentiation in the areas of adverse events (AEs), convenience and clinical and biomarker efficacy will be key determinants of future uptake.
The U.S. FDA’s accelerated approval of ADUHELM based on biomarker endpoints (i.e., decreased amyloid levels in the brain) opened the gate for U.S. regulatory submission based on similar data from other disease-modifying therapies (DMTs). The phase 3 trial readout for lecanemab validates the clinical efficacy of agents in this class, positions the drug for global regulatory approvals and bodes well for the phase 3 trial results for donanemab, which are still pending.
December 2021:
• Fast Track designation: U.S. FDA
March 2022:
• Submission under the “prior assessment consultation”: Pharmaceuticals and Medical Devices Agency (PMDA)
July 2022:
• Biologics License Application (BLA) accepted and priority review granted: U.S. FDA
January 6, 2023:
• Granted accelerated approval: U.S. FDA
Expected launch:
• 2023: United States
• 2024: Japan and Europe
Patents estimated to expire beginning in 2025
Access global intelligence, advanced analytics and global experts from Clarivate.