Lilly wins FDA approval for once-weekly Onswik insulin injection
Eli Lilly won U.S. Food and Drug Administration approval on Sept. 24 for Onswik, a once-weekly basal insulin for adults with type 2 diabetes. The treatment, also known as insulin efsitora alfa-gobe, is designed to maintain basal insulin coverage for seven days. Lilly said it could eliminate more than 300 injections annually compared with daily basal insulin.
The approval follows four Phase 3 QWINT trials involving more than 3,400 adults with type 2 diabetes. Onswik achieved non-inferior A1C reductions compared with daily insulin glargine or insulin degludec. Lilly reported an overall safety profile similar to the daily basal insulins studied. The company expects its prefilled KwikPen to reach U.S. patients in the coming months.
Onswik adds to Lilly’s diabetes portfolio as weekly insulin competes with existing daily treatments and other newer diabetes medicines. Novo Nordisk also received U.S. approval for its once-weekly insulin Awiqli earlier this year.
Why it matters
The approval gives Lilly another commercial opportunity in diabetes care while potentially reducing injection burden for patients. It also intensifies competition in the growing weekly-insulin market.
