AstraZeneca (AZN) Slumps as FDA Requests Additional PLATO Data for BRILINTA
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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.
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