The FDA has approved the once-weekly injectable basal insulin drug insulin efsitora alfa-gobe (Onswik, Eli Lilly) for use as an adjunct with diet and exercise to help control blood sugar in adults with type 2 diabetes (T2D).

The once-weekly efsitora regimen "is designed to reduce injections by over 300 per year versus once-daily basal insulin," Lilly reported in a news release.

The action marks the second such FDA approval for a long-acting, once-weekly insulin, following the March approval of Novo Nordisk's competing insulin icodec-abae (Awiqli).

Efsitora, with a fixed-dose regimen delivering steady basal insulin levels over 7 days, is expected to be available in the US in coming months in prefilled pens with two concentrations — U-500 (500 units/mL), delivering a maximum of 400 units per single injection, and U-1000 (1000 units/mL), delivering a maximum of 800 units per injection.

The approval is the fourth for efsitora; the product has received previous approvals from the European Medicines Agency, the Federal Commission for the Protection against Sanitary Risks in Mexico, and Japan's Pharmaceuticals and Medical Devices Agency.

QWINT Clinical Trials Showed Noninferiority 

The FDA approval was supported by evidence from the phase 3 QWINT clinical trial program, involving more than 3400 adults with T2D in four international trials, showing noninferiority of efsitora in comparison with once-daily insulin glargine U-100 and with insulin degludec U-100 in the reduction of A1c from baseline.

All trials showed safety profiles of efsitora that were similar to the basal insulin comparators.

In the most recent QWINT-1 trial, published in the New England Journal of Medicine, the fixed-dose regimen of efsitora in patients with T2D who had not been previously treated with insulin was comparable to once-daily glargine, with notable reductions in clinically significant or severe hypoglycemia (rate ratio, 0.57).

"This straightforward fixed-dose regimen of once-weekly efsitora, which mimics the approach used for once-weekly incretin-based therapies, may simplify treatment and lead to a lower injection burden than that with the traditional sliding-scale dose adjustments of once-daily insulin therapies," the authors wrote.

Clifford J. Rosen, MD, who co-authored an editorial published concurrently with the study, told Medscape Medical News the FDA approval "will provide another option for individuals who require insulin to be able to inject less often and may improve overall compliance, particularly in individuals with other co-morbidities."

In the editorial, the authors also noted the increasing number of options for glucose control, including newer GLP-1 receptor agonist drugs and dose adjustment options with icodec. 

In the year since the publication of the editorial, the treatment landscape has only continued to "change dramatically," said Rosen, who is director of clinical and translational research and a senior scientist at MaineHealth Institute for Research, in Scarborough, Maine.

"The use of the GLP-1RAs has grown exponentially in T2D, and most patients can tolerate the gastrointestinal side effects that previously were thought to limit widespread use," he noted. "In addition, the second and third generation double and triple agonists have been shown to be even more effective for weight loss as well as glucose tolerance than the single agonists."

That being said, "there is still a niche for long-acting insulin, particularly in those individuals who have little or no residual insulin secretion and have longstanding T2D," he concluded.

Lilly underscores that efsitora should not be used by patients with type 1 diabetes due to an increased risk for severe hypoglycemia, and the drug's safety and efficacy for the condition have not been established.

Rosen had no disclosures to report.