The U.S. FDA has approved Eli Lilly's donanemab, a once-monthly anti-amyloid therapy for early symptomatic Alzheimer's disease, which includes people with mild cognitive impairment as well as people in the mild dementia stage of the disease.
Branded Kisunla, the IV infusion is the first and only amyloid plaque-targeting therapy with evidence to support stopping therapy when amyloid plaques are removed, which, according to Lilly, can result in lower treatment costs and fewer infusions.
The FDA had rejected Lilly’s bid for accelerated approval of donanemab back in January 2023, issuing a CRL that cited the limited number of patients with at least 12 months of drug exposure data provided in the submission.
The drugmaker leaned on the confirmatory phase 3 TRAILBLAZER-ALZ 2 trial to form the basis of its application for traditional approval. The trial ended up demonstrating a 29% reduction in memory decline among Alzheimer's patients, however the unique trial design — allowing patients to complete treatment based on amyloid plaque assessment and included participants based on tau protein levels — gave the FDA pause. In March, Lilly revealed that the FDA's decision, originally slated for late March, would be delayed because the agency decided it needed to convene an AdComm meeting.
But donanemab got the all clear from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee last month, who voted unanimously in favor of the drug's approval.
Kisunla will go head to head against Eisai and Biogen's Leqembi, which was converted to traditional approval by the FDA for the same indication last July. Both Kisunla and Leqembi target and remove beta-amyloid plaques, toxic proteins that accumulate in the brains of people with Alzheimer's. However, with Kisunla, once amyloid plaques are reduced to minimal levels, participants can stop treatments.
