Novo’s Once-Weekly Insulin Is a No-Go with FDA Advisory Panel

Advisers to the U.S. Food and Drug Administration (FDA) voted 7–4 not to approve Novo Nordisk’s once-weekly, experimental insulin known as Awiqli, citing a lack of benefit over risk.

The FDA had previously raised concerns about the possibility of low blood sugar in people with type 1 diabetes, as well as the lack of clinical evidence to back up Novo’s suggested strategies for reducing the risks of hypoglycemia.

In the phase 3a ONWARDS-6 trial, 292 patients received once-daily degludec (Tresiba) and 290 patients received Awiqli.

At 26 weeks, Awiqli’s improvement in A1C was as good as the basal insulin Tresiba. On the other hand, Awiqli was associated with a significantly higher incidence of acute or severe hypoglycemia than Tresiba. The highest incidence occurred in the Awiqli group between days 2-4 following injection.

While the FDA usually follows the recommendations of its expert panel, it is not obligated to do so. Novo says it will continue to work closely with the FDA to identify the next steps needed to bring the treatment to market.

Awiqli was recently approved for use in the European Union. Eli Lilly is also developing its own once-weekly insulin injection, known as efsitora.

Unlike bolus (mealtime) insulin, which controls the rise in blood-sugar levels after meals, basal insulin helps control blood sugar levels throughout the day.

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