Edition:
India

Pfizer Confirms Initiation Of EU Review Of Tofacitinib With Interim Recommendations


Friday, 17 May 2019 

May 17 (Reuters) - Pfizer Inc ::PFIZER INC. - PFIZER CONFIRMS INITIATION OF EU REVIEW OF TOFACITINIB WITH INTERIM RECOMMENDATIONS.PFIZER INC - CONTINUES TO WORK WITH REGULATORY BODIES AND IS TAKING STEPS TO INFORM HEALTHCARE PROFESSIONALS IN EU/EEA ABOUT THIS INTERIM GUIDANCE.PFIZER INC - CONFIRMS THAT EMA ISSUED RECOMMENDATIONS LIMITING USE OF XELJANZ 10 MG TWICE DAILY IN SUBSET OF PATIENTS WITH ULCERATIVE COLITIS IN EU.PFIZER - RECOMMENDATIONS FROM EMA ARE TEMPORARY WHILE EMA'S COMMITTEE UNDERTAKES REVIEW OF ALL AVAILABLE EVIDENCE ON SAFETY, EFFICACY OF TOFACITINIB.PFIZER - REVIEW IS RESULT OF OBSERVATION OF INCREASED RISK OF PE WITH TOFACITINIB 10 MG TWICE DAILY IN ONGOING FDA POST-MARKETING REQUIREMENT STUDY.