BRIEF-EMA Gets Application For Conditional Marketing Authorisation For Paxlovid For Treating COVID-19

European Medicines Agency: * EMA: EMA RECEIVES APPLICATION FOR CONDITIONAL MARKETING AUTHORISATION FOR PAXLOVID (PF-07321332 AND RITONAVIR) FOR TREATING PATIENTS WITH COVID-19: 10/01/2022

* EMA SAYS EMA WILL ASSESS BENEFITS AND RISKS OF PAXLOVID UNDER A REDUCED TIMELINE AND COULD ISSUE AN OPINION WITHIN WEEKS * EMA: APPLICATION IS FOR TREATMENT OF MILD-TO-MODERATE COVID 19 IN ADULT AND ADOLESCENT PATIENTS WHO ARE AT HIGH RISK OF PROGRESSION TO SEVERE COVID 19

* EMA SAYS IN PARALLEL, EMA'S SAFETY COMMITTEE (PRAC) STARTED ASSESSMENT OF RISK MANAGEMENT PLAN (RMP) PROPOSED BY COMPANY

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