FDA approves Eli Lilly’s weekly insulin Onswik for U.S. patients, expanding competition with Novo

The U.S. Food and Drug Administration has cleared Eli Lilly’s weekly insulin product, Onswik, for use in American patients. This marks the drug’s fourth global approval after earlier clearances in Europe, Mexico and Japan.

Onswik is designed to be taken once a week, offering type 2 diabetes patients the chance to reduce more than 300 injections per year compared with daily insulin regimens.

In the Phase 3 QWINT trials involving about 3,400 adults, Onswik demonstrated non‑inferiority to standard once‑daily insulins such as insulin glargine and Novo’s insulin degludec. In the QWINT‑2 cohort, it lowered A1C by 1.34% versus a 1.26% reduction with degludec.

The approval adds a new front to the ongoing rivalry between Lilly and Novo, extending competition beyond obesity drugs into the cardiovascular and diabetes markets.