June 25, 2020 / 12:24 PM / 9 days ago

BRIEF-EMA Recommends First COVID-19 Treatment For EU Authorisation

June 25 (Reuters) - European Medicines Agency (EMA):

* COMMITTEE RECOMMENDED GRANTING A CONDITIONAL MARKETING AUTHORISATION TO VEKLURY (REMDESIVIR) FOR TREATMENT OF COVID-19 IN ADULTS AND ADOLESCENTS

* ASSESSMENT OF THE DOSSIER HAS NOW CONCLUDED WITH TODAY’S RECOMMENDATION, WHICH IS MAINLY BASED ON DATA FROM STUDY NIAID-ACTT-1

* REMDESIVIR IS THE FIRST MEDICINE AGAINST COVID-19 TO BE RECOMMENDED FOR AUTHORISATION IN THE EU

* EMA SAYS EUROPEAN COMMISSION AIMS TO GRANT A DECISION ON THE CONDITIONAL MARKETING AUTHORISATION FOR REMDESIVIR IN THE COMING WEEK

* EMA - DURING THE ASSESSMENT OF REMDESIVIR, THE CHMP HAD THE SUPPORT OF EXPERTS FROM THE COVID-19 EMA PANDEMIC TASK FORCE (COVID-ETF)

* EMA - EUROPEAN COMMISSION WILL FAST-TRACK DECISION-MAKING PROCESS AND AIMS TO GRANT A DECISION ON CONDITIONAL MARKETING AUTHORISATION FOR REMDESIVIR

* EMA SAYS MARKETING AUTHORISATION TO VEKLURY FOR TREATMENT OF COVID-19 IN ADULTS AND ADOLESCENTS FROM 12 YEARS OF AGE WITH PNEUMONIA WHO REQUIRE SUPPLEMENTAL OXYGEN Source text: (bit.ly/3exzI3p)

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