Quick Facts
FONT-SIZE Plus   Neg
Share SHARE
mail  E-MAIL

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

RELATED NEWS
Trade AZN now with 
4/20/2012 9:33 AM ET

AstraZeneca Plc (AZN: Quote,AZN.L) and Bristol-Myers Squibb Co. (BMY: Quote) 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.

Click here to receive FREE breaking news email alerts for AstraZeneca PLC and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Starbucks Corp. said Thursday after the markets closed that its second quarter profit rose 9.4% from last year, helped by higher revenue. The company's quarterly earnings per share came in line with analysts' expectations, but its quarterly revenue fell short of analysts' forecast. The world's largest specialty coffee retailer also raised its full year earnings outlook. Software giant Microsoft Corp. said Thursday after the markets closed that its third quarter profit fell 6.6% from last year, when results were boosted by special upgrade offer revenues. However, the company's quarterly earnings per share came in above analysts' expectations as did its quarterly revenue. Apple Inc. said Wednesday after the markets closed that its second quarter profit rose 7% from last year, as sales surged and margins improved amid strong sales of its iPhones. The company's quarterly earnings per share also came in above analysts' expectations as did its quarterly revenue. At the same time, the company gave a slightly downbeat revenue forecast for the current quarter.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.