logo
Share SHARE
FONT-SIZE Plus   Neg

AstraZeneca, Bristol-Myers Say FORXIGA Gets Positive CHMP Opinion In EU

AstraZeneca Plc (AZN,AZN.L) and Bristol-Myers Squibb Co. (BMY) said that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has recommended the approval of FORXIGA (dapagliflozin) tablets for the treatment of type 2 diabetes, as an adjunct to diet and exercise, in combination with other glucose-lowering medicinal products including insulin, and as a monotherapy in metformin intolerant patients.

The positive opinion was reached after the CHMP reviewed data from a comprehensive clinical development programme that included 11 core Phase III trials assessing the safety and efficacy of dapagliflozin as a once-daily oral therapy.

Dapagliflozin is an investigational selective and reversible inhibitor of sodium-glucose co-transporter 2, which works independently of insulin.

The companies noted that the CHMP's positive opinion on dapagliflozin will now be reviewed by the European Commission, which has the authority to approve medicines for the European Union.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Bank of Nova Scotia or otherwise known as Scotiabank, Friday reported lower net profit for the third quarter, in the absence of a year-ago gain. Earnings per share, however, came in line with the Street view. Further, the company said it raised its quarterly dividend by 2 cents. Non-traditional discount and variety stores operator Big Lots Inc. (BIG) Friday reported a decline in net profit for the second quarter, while net sales grew 1.2 percent from the prior year. Comparable sales for the quarter increased 2.8 percent. Google has rejected the European Union's charges that it abused its market power and the demanded that it change the way it ranks online comparison shopping services in its search results, setting up a potentially long legal battle with the EU regulator empowered to levy billions of euros in fines
comments powered by Disqus
RELATED NEWS
Trade AZN now with 
Follow RTT