The U.S. Food and Drug Administration announced Monday the full approval of Eli Lilly's donanemab, sold under the brand name Kisunla, for the treatment of early symptomatic Alzheimer's disease in adults showing confirmed amyloid pathology. The decision, which upgrades the drug's status from its 2024 accelerated approval, comes after the agency completed its review of long-term safety data from the TRAILBLAZER-ALZ 2 trial, which enrolled more than 1,700 patients across 56 sites in the United States and Europe.
The timing of the announcement carries particular resonance, arriving just days after a prominent Bay Area fundraising event drew researchers and philanthropists to discuss the future of Alzheimer's funding. Advocates at that gathering had specifically cited regulatory clarity around donanemab as a critical next step for accelerating insurance coverage and broadening patient access. Lilly's stock rose approximately 6% in pre-market trading Monday in response to the news, with analysts at Morgan Stanley revising their peak annual revenue estimate for Kisunla upward to $8.2 billion by 2030.
Dr. Teresa Buracchio, acting director of the FDA's Office of Neuroscience, said in a statement that the full approval reflects confidence in the drug's demonstrated ability to slow cognitive and functional decline in patients with early-stage disease. The pivotal trial showed an 18-month slowing of clinical progression by 35% compared to placebo among patients with low-to-medium tau burden, the subgroup Lilly has consistently highlighted. The label approved Monday includes that tau stratification as a recommended patient selection criterion, a nuance that will shape how neurologists prescribe the drug.
The approval is expected to intensify pressure on the Centers for Medicare and Medicaid Services to expand its current coverage framework for anti-amyloid therapies, which has been criticized as administratively burdensome since the agency approved Leqembi in 2023. The Alzheimer's Association immediately called on CMS Administrator Dr. Mehmet Oz to issue updated guidance removing the requirement for patients to enroll in registries as a condition of Medicare reimbursement, arguing the stipulation has depressed uptake of the drug class broadly. Biogen, whose competing therapy Leqembi already holds full approval, acknowledged the competitive development but maintained that its own AHEAD 3-45 prevention trial data, expected mid-year, could differentiate its drug in a pre-symptomatic population.
Clinicians welcomed the news cautiously, noting that practical barriers — including the need for PET scans or cerebrospinal fluid tests to confirm amyloid status and infusion infrastructure to administer the monthly intravenous treatment — remain significant. Major academic medical centers including UCSF Memory and Aging Center, Massachusetts General Hospital, and the Cleveland Clinic said they were reviewing updated prescribing protocols and expected to begin transitioning eligible patients from clinical trial follow-up to commercial treatment within 60 days. Safety monitoring for amyloid-related imaging abnormalities, or ARIA, will remain a key component of the post-marketing commitments Lilly accepted as a condition of the full approval.