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Novo seeks US FDA approval for oral diabetes treatment in 2 indications

Novo Nordisk A/S submitted two new drug applications with the Food and Drug Administration for the oral version of its type 2 diabetes medicine semaglutide along with a supplemental new drug application for its other diabetes medicine Ozempic.

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The company's application for oral semaglutide is supported by results from 10 clinical trials conducted under a global program called Pioneer. Novo's oral semaglutide worked better than Merck & Co. Inc.'s Januvia, or sitagliptin, in reducing blood sugar levels in one of the studies, called Pioneer 3.

The Denmark-based pharmaceutical company has used a priority review voucher for the application and expects a decision by the FDA in six months after the submission. The FDA normally takes 10 months to decide on an application.

Novo is also seeking approval from the US regulator to market oral semaglutide to reduce cardiovascular risk in adult patients with type 2 diabetes. The application is based on results from the Pioneer 6 trial, in which oral semaglutide was added on top of standard of care therapy to determine its effectiveness against placebo.

Novo also submitted a supplemental drug application for a weekly dose of Ozempic, an injectable version of semaglutide, to reduce cardiovascular risk in adult patients with type 2 diabetes. The company's application is based on results from a phase 3 trial called Sustain 6 in which Ozempic reduced the risk of major adverse heart events by 21% compared to placebo.

The FDA approved Ozempic for adults with type 2 diabetes in December 2017.

The two applications for Ozempic and semaglutide to treat patients at the risk of cardiovascular events will be reviewed under the FDA's standard period of 10 months.