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European Medicines Agency considers rapid approval of Merck's oral anti-corona drug |
Xinhua News Agency, Brussels, October 5 (Reporter Ren Ke) The European Medicines Agency said on the 5th that it would consider starting the rapid approval of the oral anti-coronavirus drug monabigravir developed by Merck in the United States
Europe FDA vaccine departments Marco Cavalieri day at a regular press conference that Europe FDA advisory committee will consider the program to start in the next few days, quick approval Mona Bila Wei , Will also assess whether the existing relevant data can support this rapid approval process
Committee member
On the 1st, Merck announced the interim analysis data of the phase III clinical trial of monabiravir jointly developed by it and Richbuck Biopharmaceuticals.
Merck issued a statement that due to the positive results, based on independent data monitoring committee will advise and communicate with the US Food and Drug Administration, has been terminated early Ⅲ clinical trials, and plans to submit an Emergency Use Authorization application to the US FDA as soon as possible , And will also submit listing applications to regulatory agencies in other countries and regions around the world as soon as possible
Committee member
Cavalieri also said at the press conference that as of now, at least 10 EU member states have decided to vaccinate their nationals with booster shots
The European Medicines Agency announced on the 4th that it supports people aged 18 and over to receive a booster shot of Pfizer's new crown vaccine.
Focus on the new crown pneumonia epidemic