Novo Nordisk Seeks FDA OK for Oral Semaglutide in Adults With Type 2 Diabetes

   By Colin Kellaher 
 

Novo Nordisk A/S (NVO) on Wednesday said it filed a pair of new-drug applications with the U.S. Food and Drug Administration seeking approval of oral semaglutide for blood-sugar control and cardiovascular risk reduction in adults with type 2 diabetes.

The Danish drug maker said it used a priority review voucher with the NDA seeking approval of the pill as an adjunct to diet and exercise to improve blood sugar. The voucher will reduce the FDA review period to six months from the usual 10.

Novo said the second NDA seeks approval of the drug to reduce the risk of major adverse cardiovascular events, such as heart attack, stroke or death, in adults with type 2 diabetes and established cardiovascular disease.

The company said it also filed a supplemental new-drug application seeking approval of its once-weekly Ozempic injection to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease.

The FDA approved Ozempic in December 2017 as an adjunct with diet and exercise to improve blood sugar in adults with type 2 diabetes.

Write to Colin Kellaher at [e-mail]

(END) Dow Jones Newswires

March 20, 2019 10:54 ET (14:54 GMT)

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