After racking up a trio of regulatory wins overseas, Eli Lilly’s once-weekly insulin is coming home to open a new front in the company’s ongoing market showdown with Novo.
The FDA has signed off on Lilly’s Onswik, also known as insulin efsitora alfa-gobe, as a new once-weekly basal insulin to help keep blood sugar in check in patients with type 2 diabetes.
With the green light, Lilly will now be able to introduce a direct competitor to Novo’s Awiqli in the U.S.
Approved in late March, Awiqli, Novo’s own solution to daily basal insulin shots, has managed to eke out a commercial head start over Lilly’s drug, in a dynamic that echoes the rollout of the companies’ oral obesity medications earlier this year.
Meanwhile, the new FDA go-ahead marks Onswik’s fourth global regulatory win, following actions from regulators in the European Union, Mexico and Japan.
The FDA’s decision leveraged data from Lilly’s late-stage Qwint program, which looked at Onswik in more than 3,400 patients with type 2 diabetes. In each trial, the drug met the primary endpoint of non-inferior A1C reduction from baseline compared with insulin glargine or insulin degludec.
Breaking things down, Onswik helped curb patients’ A1C by 1.31% versus 1.27% for insulin glargine at 52 weeks in Qwint-1, which looked at patients with type 2 diabetes using insulin for the first time. The drug reduced A1C by 0.86% at week 26 in Qwint-3 and 1.07% over that same span in Qwint-4, compared with 0.75% for insulin degludec and 1.07% for insulin glargine, respectively.
Qwint-3 assessed patients who had previously used basal insulin, while the fourth Qwint study looked at those who had previously used daily basal insulin and mealtime insulin. Qwint-2, meanwhile, stratified insulin-naive patients based on whether they were also using a GLP-1 receptor agonist. Onswik was non-inferior to insulin degludec regardless of GLP-1 use.
By 2030, more than 510 million people around the world are expected to be living with diabetes, mainly as type 2 disease, and some 37 million are expected to use insulin, according to Lilly.
"For over a century, Lilly has been developing insulins that transformed diabetes care for millions of people worldwide, but delays in initiating treatment and the burden of daily injections can have a real impact on patients' day-to-day experience managing type 2 diabetes," said Kenneth Custer, Ph.D., Lilly’s EVP and president of cardiometabolic health, in a statement.
With an approval in hand, Lilly says it plans to launch Onswik in the U.S. “in the coming months.” The company is rolling out the product in 500 units/mL and 1,000 units/mL concentrations.
As Lilly gets its ducks in a row for the Onswik launch, Novo is now coming up on the second month of Awiqli’s U.S. market run. The Danish drugmaker debuted its weekly insulin on Aug. 11.
While insulin remains a key backbone of both Lilly’s and Novo’s businesses, and a reminder of the metabolic medicine makers’ long histories addressing diabetes, the companies’ GLP-1 medicines have stolen center stage in recent years, particularly in their blockbuster obesity indications.