Novo Nordisk's (NVO) Semaglutide Gets Positive CHMP Opinion
Zacks Investment Research | Dec 18, 2017 05:35AM ET
Novo Nordisk (CO:NOVOb) (NYSE:NVO) announced that the Committee for Medicinal Products for Human Use (“CHMP”) under the European Medicines Agency (“EMA”) has given a positive opinion recommending marketing authorisation of Ozempic (semaglutide) for the treatment of adults with type II diabetes mellitus.
Semaglutide is a once-daily pre-filled pen to improve glycaemic control in type II diabetes patients. The indication also refers to specific sections of the label for study results with respect to combination with other diabetes medications, effects on glycaemic control, cardiovascular events and the populations studied.
The label also demonstrates that people with type II diabetes, who are treated with once-weekly semaglutide experienced statistically significant and sustained blood glucose control compared with Merck’s (NYSE:MRK) Januvia (sitagliptin), Astrazeneca’s (NYSE:AZN) once-weekly Bydureon (exenatide extended-release), Sanofi’s (NYSE:SNY) Lantus (insulin glargine) and placebo.
Novo Nordisk plans to conduct post-approval safety studies including a long-term diabetic retinopathy outcome study in order to get semaglutide approved in Europe. Also, the company expects to receive final marketing authorization from the European Commission in the first quarter of 2018.
We remind investors that in December, the FDA approved its semaglutide once-daily pre-filled pen to improve glycaemic control in type II diabetes patients.
Shares of the company have rallied 46.5% compared with the industry ’s gain of 17.2% on a year-to-date basis.
Additionally, Novo Nordisk is making efforts to develop new treatments for diabetes, which is its core area of expertise. In September 2017, the company received approval for its fast acting insulin aspart, Fiasp. Other than semaglutide, Novo Nordisk key pipeline candidate includes nonacog beta pegol.
GLP-1 market, which includes Lilly’s Trulicity and AstraZeneca Plc's once-weekly Bydureon might be a tough competition to Novo Nordisk’s semaglutide.
Zacks Rank
Novo Nordisk carries a Zacks Rank #3 (Hold). You can see .
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