Novo Nordisk Seeks FDA OK for Oral Semaglutide in Adults With Type 2 Diabetes
21 March 2019 - 02:09AM
Dow Jones News
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 colin.kellaher@wsj.com
(END) Dow Jones Newswires
March 20, 2019 10:54 ET (14:54 GMT)
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