News Novo Nordisk resubmits Ozempic for FDA review with new...

Novo Nordisk resubmits Ozempic for FDA review with new dosing regimen


Novo Nordisk is launching a new dosage regimen for Ozempic for the second phase. After a rejection by FDA in March, the diabetes experts are applying for approval to compete with the previously authorized higher doses of Ozempic of Eli Lilly.

Novo is aiming to get approval for a 2mg once a week dose of Ozempic ( a Glucagon-like Peptide-1 medication), which has already approved a dosage of 0.5mg to 1mg per week. Following an FDA rejection for approval of the application indicating major flaws in the company’s request, the firm has made another try to get FDA’s authorization.

In March, a representative of Novo Nordisk stated that the FDA had requested further information regarding a production facility in Denmark. The representative said that they did not suspect that the company has to submit additional clinical information to obtain a label extension for Ozempic.

Just after Eli Lilly launched 3mg and 4.5mg doses for Trulicity in the United States, Novo Nordisk submitted its application for a 2mg dose of Ozempic.

Ronny Gal, a Bernstein researcher stated in January, that although both firms are requesting larger doses of Ozempic and Trulicity, the lower dose formulations will remain the “workhouse” forms for both drugs. “While the stronger versions boast greater efficacy, the side effect burden is higher, and patients’ failure to stick to therapies is already a major issue in diabetes treatment, ” he said.

Novo is also presumably thinking about the diabetic drug of Eli Lilly, Tirzepatide, a combination GIP/GLP-1 agonist that outperformed Ozempic in a one-on-one experiment. Tirzepatide surpassed Ozempic in lowering the blood glucose concentration and body weight at all the 3 doses evaluated in the late phase analysis.
The lower dosage of both of the medications, 1mg of Ozempic and 5mg of Tirzepatide are mostly used worldwide, according to Ronny Gal. The 2mg Ozempic dosage, that Novo is seeking approval for, was not compared with Tirzepatide in the analysis.

Last year, Ozempic’s sales of $3.42 billion were surpassed by $5.07 billion sales of Trulicity. Nonetheless, Novo is hopeful that Rybelsus, its newly launched oral semaglutide alternative, can help fill the gap. This drug accounted for 4.7% of the overall GLP-1 prescription share in the United States, as well as 11.5% of total new-to-brand stakes.

Rybelsus appears to be acceptable by patients who have never used a GLP-1 drug before. That group of patients accounted for over 80% of Novo’s new prescriptions.

Novo is planning to launch another GLP-1 drug. It has made an application to FDA, for semaglutide with a dose of 2.5 mg under the skin, which is used to treat obesity. Novo has managed to enter in a “full go mode” for the launching of its obesity drug, before the expected approval by the end of the year, according to Executive Vice President of North America, Doug Langa.

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