The company is hoping its pill will be approved as an adjunct to diet and exercise to improve blood sugar control in adults with Type 2 diabetes. Novo Nordisk also submitted for approval of an indication related to risk reduction of major adverse cardiovascular events.
For the blood sugar control indication, Novo Nordisk submitted a priority review voucher and reported that it expects to hear back from the FDA within six months.
Novo Nordisk’s oral semaglutide has been studied in clinical trials involving 9,543 adults with Type 2 diabetes.
The company also filed a supplemental application for its once-weekly Ozempic semaglutide injection, going after an indication to reduce the risk of major adverse cardiovascular events. The FDA approved Ozempic for adults with Type 2 diabetes in Dec. of 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,” VP & CMO Todd Hobbs said in prepared remarks.
“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,” he added.
Novo Nordisk plans to launch its connected insulin pens, the NovoPen 6 and NovoPen Echo Plus, in early 2019. Any provider using diasend and any person using the diasend mobile app will be able to sync data from Novo Nordisk’s connected pens, according to Glooko.