November 12, 2018 / 6:28 AM / a month ago

BRIEF-Sanofi: Analyses On Mortality From ODYSSEY OUTCOMES Trial Of Praluent

Nov 12 (Reuters) - SANOFI SA:

* ANNOUNCED ON SUNDAY ANALYSES ON MORTALITY FROM THE 18,924-PATIENT ODYSSEY OUTCOMES TRIAL

* PRALUENT® (ALIROCUMAB) WAS ASSOCIATED WITH FEWER DEATHS IN PATIENTS WHO HAD EXPERIENCED A HEART ATTACK OR UNSTABLE ANGINA

* ADDITIONAL NEW ANALYSES SHOWED AN ASSOCIATION BETWEEN REDUCED NON-FATAL CARDIOVASCULAR (CV) EVENTS AND REDUCTION IN NON-CV DEATH DURING THE TRIAL PERIOD

* PRALUENT ADDED TO MAXIMALLY-TOLERATED STATINS WAS COMPARED TO MAXIMALLY-TOLERATED STATINS ALONE IN PATIENTS WHO HAD EXPERIENCED AN ACS WITHIN THE LAST 12 MONTHS

* NO NEW SAFETY SIGNALS WERE FOUND IN THE ANALYSES

* DATA HAVE BEEN SUBMITTED TO REGULATORY AUTHORITIES, TARGET ACTION DATE FOR FDA DECISION IS APRIL 28, 2019

Source text for Eikon: Further company coverage: (Gdynia Newsroom)

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