BRIEF-EMA Ends Rolling Review Of Antibodies For COVID-19 Following Withdrawal By Lilly
Nov 2 (Reuters) - European Medicines Agency:
* EMA: EMA ENDS ROLLING REVIEW OF THE ANTIBODIES BAMLANIVIMAB AND ETESEVIMAB FOR COVID-19 FOLLOWING WITHDRAWAL BY LILLY: 02/11/2021
* EMA SAYS ALTHOUGH EMA WAS SPEEDING UP ITS REVIEW OF DATA, SOME QUESTIONS ABOUT MEDICINES' QUALITY REMAINED TO BE SATISFACTORILY ADDRESSED
* EMA SAYS AT TIME OF COMPANY'S WITHDRAWAL, EMA HAD RECEIVED NON-CLINICAL (LABORATORY) DATA, DATA FROM CLINICAL STUDIES
* EMA SAYS WITHDRAWAL WAS A DECISION BY COMPANY AND REASONS CAN BE FOUND IN COMPANY'S LETTER OF WITHDRAWAL
* EMA SAYS COMPANY RETAINS RIGHT TO REQUEST ANOTHER ROLLING REVIEW OR SUBMIT A MARKETING AUTHORISATION APPLICATION IN FUTURE
* EMA: WITHDRAWAL HAS NO CONSEQUENCES ON PREVIOUS ADVICE ISSUED IN MARCH AND PATIENTS MAY CONTINUE TO RECEIVE MEDICINES BASED ON NATIONAL ARRANGEMENTS
