It is an antiviral that slows down the production of new virus particles, allowing severely ill patients to recover an average of four days earlier than usual.
Although the European Commission (EC) will have to make the final decision on this antiviral, this is the first drug to pass the EMA evaluation, which was done in an exceptionally short period through a continuous review procedure.
The "conditional" authorization by the EMA to sell a drug means that it can be marketed earlier than the usual time it takes for the authorization of a drug under normal conditions.
This emergency process is only followed if the benefit of the immediate availability of medicine is greater than the inherent risk of the lack of complete information about the product.
Remdesivir's preliminary non-clinical and clinical data started to be analyzed by the EMA's Human Medicines Committee (CHMP)on April 30. The application for a European drug sale authorization was presented on June 5.
Remdesivir is an experimental therapy developed in 2009 and was tested with Ebola patients in the middle of the past decade. It has been licensed for the SARS-CoV-2 coronavirus because a U.S. clinical trial showed that it shortens the recovery time in some patients.
The evaluation of the drug by the European authorities took into account the results of a study carried out by the U.S. National Institute of Allergy and Infectious Diseases (NIAID), whereby over 1,000 critically ill patients were tested in 75 hospitals in different countries.
Hospitalized patients who took Remdesivir recovered an average of 31 percent faster than those patients who took a placebo.
"Patients treated with Remdesivir recovered after about 11 days, compared with 15 days for patients given a placebo. This effect was not observed in patients with mild to moderate disease: time to recovery was 5 days for both the Remdesivir group and the placebo group," the EMA reported.
"For patients with severe disease, who constituted approximately 90 percent of the study population, time to recovery was 12 days in the Remdesivir group and 18 days in the placebo group. However, no difference was seen in time to recovery in patients who started Remdesivir when they were already on mechanical ventilation," it added.
The European Commission is scheduled to approve the marketing of this drug under the name Veklury. So far, however, it is unclear how many Remdesivir doses will be available for the EU market as this will need to be negotiated with the U.S. company Gilead Sciences.