CeleCor submits FDA application for investigational heart attack drug
Singapore, June 25 -- CeleCor Therapeutics has completed submission of its New Drug Application to the U.S. FDA for zalunfiban, its investigational heart attack drug.
The filing follows positive Phase III results from the CeleBrate study, which were presented at the American Heart Association Scientific Sessions and published in The New England Journal of Medicine Evidence. Zalunfiban has FDA Fast Track status and was granted Rolling Review in January, allowing the company to submit sections of the application as they became available.
This is relevant because ST-segment elevation myocardial infarction, or STEMI, is the most severe form of heart attack. Clinical outcomes depend heavily on how quickly the blocked coronary artery is reope...
Click here to read full article from source
To read the full article or to get the complete feed from this publication, please
Contact Us.