Novo Nordisk’s Awiqli has won FDA approval as the first once-weekly basal insulin for adults with type 2 diabetes. For people who use basal insulin, that shift from once-daily to once-weekly injections is a big deal. It reduces the burden of treatment and could make insulin therapy feel more manageable over time, especially for those who find daily injections tiring or difficult to maintain.

The approval is based on the ONWARDS phase 3a program in adults with type 2 diabetes. Across those trials, once-weekly insulin icodec showed HbA1c reduction, with a safety profile overall consistent with the daily basal insulin class. Novo Nordisk expects to launch Awiqli in the U.S. in the second half of 2026.

The broader regulatory context also matters here. Novo Nordisk had previously pursued U.S. approval for insulin icodec in type 1 diabetes, but that effort ran into FDA concerns about hypoglycemia. This approval is narrower and focused on adults with type 2 diabetes, where the practical benefit of moving from a daily routine to a once-weekly one may stand out most clearly.

Update

Early reaction from clinicians suggests that Awiqli’s once-weekly dosing could make basal insulin easier for many people with type 2 diabetes to start and maintain. But alongside the enthusiasm, there are already practical questions about missed doses, real-world safety, cost, access, and how it will fit into day-to-day diabetes care.

Sources

Novo Nordisk Press Release
Drug Topics Coverage
LinkedIn Discussion