The European Commission granted conditional marketing authorization for Remdesivir on Friday, making it the first EU-authorized drug to treat COVID-19, the institution said in a press release. The authorization follows a recommendation from the European Medicines Agency (EMA), followed by approval from the Member States.
The European Commission prioritizes public health, which is why Remdesivir data were assessed in an exceptionally short time frame through an ongoing review procedure, an approach used by the EMA in public health emergencies to assess the data as they become available, the institution shows, in a press release sent, on Friday.
This allowed the authorization to be granted quickly in the context of the coronavirus crisis, within one week of the EMA recommendation, compared to the usual 67-day deadline.
“The fact that today we authorized the first drug to treat COVID-19 is a big step forward in the fight against this virus. We grant this authorization less than a month after the application is submitted, clear evidence of the EU’s determination to respond quickly whenever new treatments become available. We will spare no effort to ensure effective coronavirus treatments or vaccines, “said Health and Safety Commissioner Stella Kyriakides, according to the source.
Remdesivir now has a conditional marketing authorization, one of the EU’s regulatory mechanisms designed to facilitate rapid access to medicines that meet an unmet medical need, including those for emergencies in response to health threats. such as the current pandemic.