Eli Lilly and Company wins FDA approval for weekly Onswik insulin
FDA cleared the weekly basal insulin for adults with type 2 diabetes on Sept. 24; Lilly expects the U.S. pen in the coming months.
Adrian Kessler
An FDA approval has opened the way for a second once-weekly basal insulin in the U.S. as the agency cleared Onswik for Eli Lilly and Company NYSELLY on Sept. 24. Lilly said in its Sept. 24 release that weekly dosing is designed to spare more than 300 injections a year compared with daily basal insulin.
The decision covers adults with type 2 diabetes using the drug alongside diet and exercise. Lilly expects the Onswik KwikPen to be available in the U.S. in the coming months, but its Sept. 24 release gave neither a price nor a firm launch date.
Lilly is an Indianapolis drugmaker with marketed insulin and incretin medicines for diabetes. The new product adds a weekly basal option to that portfolio, a different dosing schedule from the daily insulins against which it was tested.
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Lilly shares were nearly flat at US$1,183.46 on the New York Stock Exchange on Friday, Sept. 25, according to the NYSELLY quote page at 4:03 p.m. EDT.
Four Trials Found Comparable A1C Reduction
The FDA's Sept. 24 account describes four randomized, open-label, active-controlled trials in adults starting insulin, switching from daily basal insulin or already receiving basal and mealtime insulin. Once-weekly Onswik reduced A1C, a measure of average blood sugar, to a similar extent as daily insulin glargine or insulin degludec.
In its Sept. 24 release, Lilly said the QWINT program enrolled more than 3,400 adults and met the primary noninferiority endpoint in each trial. QWINT-1 randomized 795 insulin-naive adults to weekly efsitora or daily glargine for 52 weeks. QWINT-4 randomized 730 adults already using basal and mealtime insulin to weekly efsitora or daily glargine, both with mealtime lispro, for 26 weeks.
Reducing injections changes the treatment schedule, while the Sept. 24 FDA notice evaluates Onswik through blood sugar control. Neither that notice nor Lilly's release reports a comparative adherence measure or evidence of fewer diabetes complications.
"Onswik offers a new once-weekly basal insulin option for patients and reflects our continued commitment to deliver innovative treatment options that expand choice and provide greater flexibility in how people manage type 2 diabetes," Kenneth Custer, Lilly's executive vice-president and president of cardiometabolic health, said in the Sept. 24 release.
The U.S. label revised in September 2026 warns of severe hypoglycemia, accidental overdose and medication errors. Onswik is not recommended for patients with type 1 diabetes because of an increased risk of severe hypoglycemia.
FDA Calls Onswik the Second Weekly Insulin
The FDA said on Sept. 24 that Onswik is the second once-weekly insulin approved for adults with type 2 diabetes. For a listed market comparison, U.S. depositary shares of Novo Nordisk A/S NYSENVO closed at US$38.80 in New York on Sept. 25, according to its NYSENVO quote page at 4:00 p.m. EDT.
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Lilly's Sept. 24 release says its pen will be offered in two concentrations, 500 and 1,000 units per millilitre. The September 2026 label lists 1,500 units in the lower-strength pen and 3,000 in the higher-strength one. It warns against drawing insulin from either pen into a syringe because that can cause an overdose.
Lilly's investor calendar schedules its third-quarter earnings call for Oct. 29 at 10 a.m. EDT.
