Lilly wins US approval for once-weekly insulin Onswik

Eli Lilly ($LLY) received FDA approval for Onswik, its once-weekly basal insulin for adults with type 2 diabetes, used alongside diet and exercise. The decision gives the company a less frequently administered alternative to daily basal insulin. Lilly expects its prefilled pen to become available in the coming months, with the weekly schedule potentially eliminating more than 300 injections a year.

Approval was supported by four Phase 3 QWINT trials involving more than 3,400 adults. The studies established noninferior blood-sugar control against daily insulin comparators, rather than superiority. Onswik is not approved for type 1 diabetes, and important insulin-related risks, including severe hypoglycemia, remain. Commercial availability and uptake are still ahead of the regulatory decision.

Sources:

• Lilly — approval announcement, PR Newswire reprint