Eva Deschamps / October 26, 2021
The European Medicines Agency EMA will submit the anti-Covid drug from U.S. pharmaceutical companies Merck and Ridgeback Bio to a continuing review, it announced Monday.
If the pill, called molnupiravir, gets the green light, it would be the first oral coronavirus drug to be approved.
The rolling review process allows the EMA to evaluate safety and efficacy data as they come in. Therefore, there is no need to wait for a formal application from the producer. The objective is to speed up the evaluation of an application if it is actually submitted.
The two companies themselves announced the results of the Phase 3 study earlier this month. The study appears to show that the treatment reduced the risk of hospitalization or death in the event of infection by half.