Novo Nordisk says it is planning to launch its once-weekly type 2 diabetes treatment Ozempic® (semaglutide injection) early in 2018 following approval yesterday by the FDA.

Ozempic is a glucagon-like peptide 1 (GLP-1) receptor agonist indicated as an adjunct to diet and exercise. The agency authorized the marketing of Ozempic six weeks after the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee recommended approval of the therapy by a 16 to 0 vote with one abstention.

The advisory panel heeded the finding of a briefing document by agency staffers that showed favorable results for Ozempic in five Phase III trials (SUSTAIN 1, 2, 3, 4, and 5) and a two-year cardiovascular outcomes trial (SUSTAIN 6) compared to placebo and three competing diabetes treatments: Merck & Co.’s Januvia® (sitagliptin), Sanofi’s Lantus® (insulin glargine), and AstraZeneca’s Bydureon® (semaglutide injection).

“Both doses of semaglutide (0.5 mg and 1.0 mg) demonstrated superiority to placebo, in terms of change in HbA1c from baseline, in a monotherapy trial as well as in a trial with basal insulin background therapy,” according to the briefing document, in which Jiwei He, Ph.D., summarized the drug’s efficacy. “Both doses of semaglutide also demonstrated superiority to active comparators sitagliptin and insulin glargine for the HbA1c primary endpoint. Semaglutide 1.0 mg also demonstrated superiority to exenatide ER.

In all, Ozempic was evaluated in eight Phase IIIa trials in which more than 8000 adults with type 2 diabetes were enrolled.

One of those trials was SUSTAIN 7, for which Novo Nordisk trumpeted positive results in August. In that study, semaglutide showed superiority to Eli Lilly’s Trulicity® (dulaglutide). From a mean baseline HbA1c of 8.2%, a 0.5-mg dose of semaglutide achieved reduction of 1.5% compared with a 1.1% reduction for a 0.75-mg dose of dulaglutide. Patients treated with a 1.0-mg dose of semaglutide experienced a statistically significant and superior reduction of 1.8% compared with a 1.4% reduction for dulaglutide at a 1.5-mg dose.

Next year, Novo Nordisk plans to launch two trials designed to assess the effects of Ozempic in reducing weight: The STEP Phase IIIa trial, expected to enroll approximately 4500 people with obesity, and a cardiovascular outcome trial with an expected enrollment of approximately 12,500 people.

Blockbuster Sales Projected

To comply with post-approval requirements, Novo Nordisk said, it will also conduct a trial assessing Ozempic in adolescents under 18 years of age, and will add Ozempic to the 15-year medullary thyroid carcinoma (MTC) registry being conducted for all other long-acting GLP-1 products.

Ozempic has been predicted to be a blockbuster, with Evaluate projecting annual sales of $2.2 billion by 2022.

That would surpass two of Ozempic’s competitors assessed in the SUSTAIN trials: Bydureon finished 2016 with $578 million and Trulicity with $925.5 million. However, the Novo Nordisk treatment’s projected sales would pale beside the $6.109 billion in sales racked up by Merck for Januvia last year, and the €5.714 billion ($6.746 billion) garnered by Sanofi for Lantus.

Ozempic is approved for use in two therapeutic dosages, 0.5 mg and 1 mg, and will be launched with the latest generation of Novo Nordisk prefilled devices, the Ozempic® Pen.

“Type 2 diabetes is a complex disease, but with the unique clinical profile of Ozempic, we believe it has the potential to set a new standard for the treatment of the disease,” Mads Krogsgaard Thomsen, D.V.M., Ph.D., D.Sc., Novo Nordisk EVP and CSO, said in a statement.

Ozempic remains under review by the European Medicines Agency and Japanese Pharmaceuticals and Medical Devices Agency.

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