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
Alphabet Inc. (GOOG, GOOGL), the parent company of Google, Thursday reported an increase in profit for the first quarter, driven largely revenue growth in search and advertising. Alphabet's first-quarter profit rose to $5.43 billion or $7.73 per share from $4.21 billion or $6.02 per share last year. On... A passenger was booted from a Delta Air Lines flight after an emergency run to the bathroom while the plane was delayed for almost two hours on the tarmac, according to media reports. Kima Hamilton, 39, reportedly said that he needed to use the restroom while the plane was on the tarmac in Atlanta en route to Milwaukee on April 18. McDonald's is going to discontinue a popular item that has been on the menu for decades - the Hi-C Orange Lavaburst - from May 1, according to a memo posted on Reditt. With customers having only a few more days to get their hands on the iconic, popular beverage before its gone forever, McDonald's is already facing a backlash for its decision.
comments powered by Disqus
Follow RTT