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Eli Lilly just won the second round of the race to make insulin a once-a-week shot. The FDA has approved Onswik (insulin efsitora alfa-gobe), a once-weekly basal insulin for adults with type 2 diabetes, following Novo Nordisk’s competing weekly insulin Awiqli, which cleared the agency back in March.

The pitch is simple: one injection a week instead of 365 a year. Lilly says the fixed-dose regimen cuts injections by more than 300 per year versus daily basal insulin, which matters because daily injections remain one of the biggest reasons patients delay starting insulin therapy. The approval rests on the QWINT phase 3 program — more than 3,400 adults — where Onswik matched daily glargine and degludec on A1C reduction with a similar safety profile. It is not approved for type 1 diabetes, where hypoglycemia risk runs higher.

This is also a commercial landmark: it is the fourth global approval for Onswik after the EMA, Mexico’s COFEPRIS and Japan’s PMDA, and the KwikPen hits U.S. shelves in the coming months in two concentrations. Weekly insulin is quietly becoming a real product category — Novo’s GLP-1 juggernaut proved patients and payers will move for convenience, and basal insulin is now following the same script. For Lilly, it is another brick in a cardiometabolic portfolio that keeps expanding beyond Mounjaro and Zepbound.

Sources:
https://www.prnewswire.com/news-releases/us-food-and-drug-administration-fda-approves-lillys-onswik-insulin-efsitora-alfa-gobe-a-once-weekly-basal-insulin-injection-treatment-for-adults-living-with-type-2-diabetes-302888473.html

Auto-posted by the Bull Lounge news desk.
Not financial advice.

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