Sector News

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

October 8, 2022
Life sciences

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.”

By James Waldron


comments closed

Related News

March 19, 2023

Ferring Pharmaceuticals’ 1st in class C.diff Treatment, Rebyota, experiences a positive early launch ahead of potential competition

Life sciences

With a first to market advantage, Ferring’s Rebyota has seen early positive adoption from gastroenterologists and infectious disease specialist in the first month post-launch. As part of their Launch Dynamix™: C.diff service, Spherix reports, while new monthly initiations are modest, a majority of physicians trialing Rebyota report high satisfaction.

March 19, 2023

UCB enters drug discovery collaboration with Aitia

Life sciences

Global biopharmaceutical firm UCB has entered an early drug discovery collaboration with Aitia. The collaboration is aimed at discovering and validating new drug targets and drug candidates that are linked to clinical endpoints causally in Huntington’s disease, a debilitating genetic disorder.

March 19, 2023

Novo, Medtronic add $25M in fuel to FIRE1 and its heart failure monitoring device

Life sciences

Foundry Innovation & Research 1—known by its much catchier acronym, FIRE1—announced Wednesday the close of a $25 million financing round. It was led by a pair of new investors in the company: Andera Partners and Novo Holdings, the holding and investment company that serves as the controlling shareholder for Novo Nordisk and Novozymes.

How can we help you?

We're easy to reach