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Novo Nordisk files new drug applications for oral, injectable semaglutide

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Novo Nordisk on Wednesday submitted two new drug applications for oral semaglutide, seeking approval for the drug as an adjunct to diet and exercise in adults with type 2 diabetes along with an indication to reduce the risk for major adverse cardiovascular events in patients with established cardiovascular disease, according to a company press release.

Additionally, Novo Nordisk filed a supplemental NDA for once-weekly injectable semaglutide (Ozempic) 0.5 mg or 1 mg, seeking an indication to reduce the risk for major adverse CV events in adults with type 2 diabetes and an established history of CVD. The injectable formulation of the drug was approved by the FDA Dec. 5, 2017.

“We are very excited about these three regulatory filings with the FDA as they represent a significant milestone for the company, but most importantly represent new potential treatment options for adults living with type 2 diabetes,” Todd Hobbs, MD, vice president and U.S. chief medical officer of Novo Nordisk, said in the release. “We know that many adults with type 2 diabetes are still struggling to control their blood sugar and are at increased cardiovascular risk. We hope that, if approved, these products can help those patients.”

The applications seeking a CV risk reduction indication for oral and injectable semaglutide follow two CV outcomes trials — PIONEER 6 and SUSTAIN 6 — that examined the effects of adding semaglutide or placebo to standard of care on the risk for major adverse CV events in adults with type 2 diabetes and established CVD. In the SUSTAIN program, semaglutide demonstrated statistically significant and sustained blood glucose control when compared in trials with sitagliptin (Januvia, Merck), exenatide extended-release (Bydureon, AstraZeneca), once-daily insulin glargine U100 (Lantus, Sanofi) and placebo. Weight loss, a secondary endpoint, was also demonstrated in all semaglutide arms.

The efficacy and safety of oral semaglutide, the first oral GLP-1 receptor agonist, was evaluated in 10 PIONEER clinical trials, which included 9,543 adults with type 2 diabetes. In the PIONEER program, people treated with oral semaglutide were compared with those taking sitagliptin, empagliflozin (Jardiance, Boehringer Ingelheim), liraglutide (Victoza, Novo Nordisk) and placebo.

Novo Nordisk submitted a priority review voucher with the application for oral semaglutide, with an anticipated review time of 6 months. The second application for oral semaglutide and the supplemental application for injectable semaglutide each have an anticipated 10-month review time, according to the company. – by Regina Schaffer

Disclosure: Hobbs is vice president and U.S. chief medical officer of Novo Nordisk.