The FDA has updated the labeling for Kisunla™ (donanemab-azbt) to include a new recommended titration dosing schedule for adults with early symptomatic Alzheimer disease.

The FDA approved a label update with a new titration schedule for donanemab (Kisunla), an anti-amyloid drug approved to treat ...

Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved a label ...

Approval was based on results from the Phase IIIb TRAILBLAZER-ALZ 6 trial, which showed that Kisunla achieved comparable ...

Lilly's Kisunla gets FDA approval for a new dosing schedule that significantly lowers ARIA-E risk while maintaining amyloid ...

NICE said it made every effort to support reimbursement for Kisunla and Leqembi, but found the medicines are “not good value for money”.

Lilly continues to study donanemab in multiple clinical trials, including TRAILBLAZER-ALZ 3, focused on reducing risk of progression to symptomatic AD in participants with preclinical Alzheimer's ...

Drugs that slow progression of Alzheimer’s don’t provide enough benefit to justify substantial cost for NHS, regulator has said ...

Two breakthrough Alzheimer's drugs have been deemed far too expensive, for too little benefit, to be offered on the NHS. The medicines are the first to slow the disease, which may give people extra ...

US FDA approves updated label for Eli Lilly's Kisunla with new dosing in early symptomatic Alzheimer's disease: Indianapolis Thursday, July 10, 2025, 14:00 Hrs [IST] Eli Lilly and ...

INDIANAPOLIS, May 21, 2025 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the Australian Therapeutic Goods Administration (TGA) has granted marketing authorization for ...