Novo Nordisk ready to submit once-weekly insulin to FDA after scoring final phase 3 win

Novo Nordisk added the final piece to the puzzle the Danish drugmaker wanted to complete before submitting its once-weekly insulin icodec to regulators next year.

Icodec already notched notable wins across its six-part Onwards phase 3 program, with parts 1, 2, 3, 4 and 6 all hitting their primary endpoints. The clinical successes raised hopes that insulin icodec will be able to address some of the issues associated with the use of once-daily basal insulin analogs such as Novo’s own Tresiba. In theory, reducing the frequency of dosing could improve convenience, adherence, quality of life and by extension, glycemic control.

On Monday, the company completed the lineup, with Onwards 5, true to form, also hitting its primary endpoint. Icodec demonstrated non-inferiority in reducing hemoglobin A1c, a measure of blood sugar, in patients with type 2 diabetes at week 52 when compared with once-daily basal insulin analogs. Specifically, participants who received Icodec saw an HbA1c reduction of 1.68% points, compared with 1.31% for patients who received once-daily basal insulins.

What set the study apart from the rest of the Onwards series was the reduced number of trial visits across the 1,085 participants, with those taking icodec also using a dosing guide app to help ensure they received the correct titration.

With the full set of icodec trials having read out, Novo can continue onwards to its hoped-for approval. It expects to make regulatory filings in the U.S., EU and China in the first half of 2023.

“These results include real-world elements and a dosing guide app, which help us better understand how insulin icodec can make a difference for patients in a clinical practice setting,” Martin Holst Lange, executive vice president for development at Novo, said in an Oct. 3 release. “We now look forward to sharing the results with regulatory authorities.”