Novo Nordisk, aiming for approval this fall, puts first-ever oral GLP-1 drug up for FDA review

Novo Nordisk
Novo is also asking the FDA to specify that the drug can reduce the risk of major adverse cardiovascular events in patients with Type 2 diabetes and established cardiovascular disease. (Novo Nordisk)

Novo Nordisk has big hopes for its new oral version of GLP-1 diabetes drug semaglutide, and on Wednesday, it took one step closer to turning those hopes into reality.

Novo officially submitted an application for the drug to the FDA, the company said in a release. It filed the drug with a priority review voucher, positioning itself for a green light later this year. The Danish drugmaker, facing tough competition from Eli Lilly's GLP-1 entrant Trulicity, is hoping its semaglutide franchise can keep a grip on that market after its daily blockbuster, Victoza, faces generics in a few years.

The voucher will shorten the FDA's review to six months.

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Besides filing the daily semaglutide pill for approval to control blood sugar in Type 2 diabetes patients, Novo is also asking the FDA to specify that the drug can reduce the risk of major adverse cardiovascular events in patients with Type 2 diabetes and established cardiovascular disease.

The company additionally filed for a similar label addition for Ozempic, its weekly injectable version of semaglutide approved in late 2017. Novo asked the FDA to expand Ozempic’s label to include a lower risk of major adverse cardiovascular events for patients with Type 2 diabetes and established cardiovascular disease. Those reviews will take about 10 months, the company said. 

RELATED: Eyeing blockbuster sales boost, Novo hits the accelerator on oral semaglutide 

Analysts believe the oral option will disrupt the increasingly competitive diabetes market, grow the entire GLP-1 class and pull in blockbuster sales. 

Novo inked a Victoza patent settlement with Teva this week that likely puts off the generic giant’s copycats until late 2023. In the meantime, the company will be tasked with growing sales for the newer drugs before blockbuster Victoza nears the patent cliff. 

RELATED: Novo's Victoza won't face Teva copies until 2023. Can semaglutide fill the gap by then? 

New revenue from the oral semaglutide launch would represent an important boost for Novo. The company has suffered from U.S. competition and payer pressure for years, and last year, discounting grew to 68% across the company’s U.S. portfolio, executives said. To cope with pricing struggles, Novo has had to cut costs. 

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