AstraZeneca (AZN) Slumps as FDA Requests Additional PLATO Data for BRILINTA
Tweet
Share
E-mailGet Alerts AZN Hot Sheet
Join SI Premium – FREE
AstraZeneca (NYSE: AZN) shares are trading lower today, following the company receiving a response from the U.S. FDA for its ticagrelor (BRILINTA) New Drug Application (NDA).
In the letter, the FDA requested "additional analyses of the PLATO data," though no additional studies were required. PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whether ticagrelor could achieve clinically meaningful cardiovascular and safety end points in ACS patients, above and beyond those afforded by clopidogrel.
BRILINTA is an oral antiplatelet treatment for acute coronary syndromes (ACS). The drug has already been granted marketing authorization under the trade name BRILIQUE by the European Commission (EC) on December 6, 2010.
AZN shares are 6% lower in early trading.
In the letter, the FDA requested "additional analyses of the PLATO data," though no additional studies were required. PLATO was a large (18,624 patients in 43 countries) head-to-head patient outcomes study of ticagrelor versus clopidogrel, designed to establish whether ticagrelor could achieve clinically meaningful cardiovascular and safety end points in ACS patients, above and beyond those afforded by clopidogrel.
BRILINTA is an oral antiplatelet treatment for acute coronary syndromes (ACS). The drug has already been granted marketing authorization under the trade name BRILIQUE by the European Commission (EC) on December 6, 2010.
AZN shares are 6% lower in early trading.
Serious News for Serious Traders! Try StreetInsider.com Premium Free!
You May Also Be Interested In
- ENHERTU® (fam-trastuzumab deruxtecan-nxki) demonstrated statistically significant and clinically meaningful improvement in PFS as 1st-line treatment of patients with HER2-mutant advanced non-small ce
- Milestone Pharmaceuticals starts Phase 3 AFib-RVR trial for etripamil
- Gossamer Bio raises up to $250M in private placement for PAH drug
Create E-mail Alert Related Categories
FDA, Insiders' Blog, Momentum MoversSign up for StreetInsider Free!
Receive full access to all new and archived articles, unlimited portfolio tracking, e-mail alerts, custom newswires and RSS feeds - and more!
