Brief: EMA Issues Advice On Use Of Regdanvimab For Treating COVID-19

Celltrion

26/03/2021 11:22

March 26 (Reuters) - European Medicines Agency: 
    * EMA SAYS ISSUES ADVICE ON USE OF REGDANVIMAB FOR TREATING
COVID-19
    * EMA SAYS CONCLUDED REGDANVIMAB CAN BE USED FOR TREATMENT
OF
CONFIRMED COVID-19 IN ADULT PATIENTS WHO DO NOT REQUIRE
SUPPLEMENTAL OXYGEN THERAPY
    * EMA SAYS RESULTS FROM THE FIRST PART OF THE STUDY INDICATE
THAT
REGDANVIMAB MAY LOWER THE RATE OF HOSPITALISATION
    * EMA SAYS HOWEVER, THE RESULTS WERE NOT ROBUST ENOUGH TO
REACH A
FIRM CONCLUSION ON THE MEDICINE’S BENEFITS AT THIS POINT IN TIME
    * EMA SAYS WHILE CURRENT EVALUATION HAS CONCLUDED, A ROLLING
REVIEW OF REGDANVIMAB, WHICH STARTED ON 24 FEBRUARY, IS
CURRENTLY ONGOING
    * EMA SAYS IN TERMS OF SAFETY, MOST SIDE EFFECTS REPORTED
WERE
MILD OR MODERATE ON REGDANVIMAB
    * EMA SAYS REACTIONS RELATED TO INFUSION (INCLUDING ALLERGIC
REACTIONS) CANNOT BE EXCLUDED, HEALTHCARE PROFESSIONALS SHOULD
MONITOR PATIENTS FOR REACTIONS
    * EMA SAYS CHMP CONCLUDED THAT REGDANVIMAB CAN BE CONSIDERED
A
TREATMENT OPTION FOR PATIENTS AT HIGH RISK OF PROGRESSING TO
SEVERE COVID-19

Source text : https://bit.ly/31o4RRE
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