BRIEF-EMA Receives Application For Marketing Authorisation For Xevudy In Treating Patients With COVID-19

GlaxoSmithKline PLC: * EMA: EMA RECEIVES APPLICATION FOR MARKETING AUTHORISATION FOR XEVUDY (SOTROVIMAB) FOR TREATING PATIENTS WITH COVID-19: 18/11/2021

* EMA: WILL ASSESS THE BENEFITS AND RISKS OF XEVUDY UNDER A REDUCED TIMELINE * EMA: XEVUDY INTENDED FOR TREATMENT OF ADULTS, ADOLESCENTS WITH COVID-19 WHO DO NOT REQUIRE SUPPLEMENTAL OXYGEN THERAPY, AT INCREASED RISK OF PROGRESSING TO SEVERE COVID-19

* EMA: COULD ISSUE AN OPINION WITHIN TWO MONTHS ON XEVUDY * EMA SAYS CHMP ASSESSED DATA FROM STUDY INTO EFFECTS OF SOTROVIMAB IN ADULT OUTPATIENTS WITH MILD COVID-19 SYMPTOMS WHO DO NOT NEED SUPPLEMENTAL OXYGEN Further company coverage:

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