The European Commission (EC) authorized on Friday the use of the drug Remdesivir to treat the coronavirus, after the European Medicines Agency (EMA) recommended last week to give the green light to the marketing of the medicine, which has shown its positive effects in the treatment of COVID-19.
The Community Executive indicated in a statement that it has granted “a conditional marketing authorization” for Remdesivir, which thus becomes “the first medicine authorized at the European Union level for treatment against COVID-19”.
The authorization has been granted in an accelerated procedure, since last week the EMA recommended to give the green light to the marketing of the drug for the treatment of COVID-19 in adults and adolescents over 12 years with pneumonia. Remdesivir is an experimental therapy that started developing in 2009 and was tested with Ebola patients in the middle of the last decade.
An American clinical trial showed that it shortens the recovery time in some patients with the coronavirus. Following the EMA recommendation, the European Commission had to give its approval, as it did this Friday.
Brussels explained that the data on Remdesivir was analyzed “in an exceptionally short period of time using a continuous review procedure,” given the public health emergency of the coronavirus.
“This has allowed the authorization to be granted quickly in the context of the coronavirus crisis, within a week after the EMA recommendation, compared to the usual 67 days,” the EC noted.
The “conditional” authorization to sell a drug means that it can be marketed with slightly less data available and before the usual time it takes for the authorization of a drug under normal conditions, facilitating rapid access to the product in contexts such as a pandemic.
“Today’s authorization of a first medicine to treat COVID-19 is an important step forward in the fight against this virus,” said European Commissioner for Health Stella Kyriakides, adding that Brussels “will not leave a stone unturned in its efforts to ensure efficient treatments or vaccines against coronavirus. “
On Thursday, the community executive said that it is negotiating with the pharmaceutical company Gilead Sciences to reserve enough doses for the European Union of Remdesivir, after the United States has secured the purchase of more than 500,000 treatments for the country’s hospitals until September.
Specifically, the volume acquired represents 100% of the production for July, and 90% for August and September.
Spain has sufficient stocks of Remdesivir to treat seriously ill patients with COVID-19 until next October.
The antiviral slows down the production of new virus particles, and as a result, such an infection develops less quickly, and critically ill patients recover an average of four days earlier than usual, according to a large study conducted. in United States.