BRUSSELS | The european Commission has authorized Friday the placing on the market conditional” of the antiviral remdésivir within the EU, used in the treatment of critically ill patients for the new coronavirus.
“We will make every effort to obtain treatments or vaccines effective against the coronavirus,” said the Health commissioner Stella Kyriakides, quoted in a press release, then that permission has been granted less than a month after the filing of the application.
The green light from the Commission came a week after the recommendation of the european medicines Agency (EMA), compared to 67 days normally, and the approval of member States. He remdésivir the “first medicine to be approved at the level of the EU for the treatment against the COVID-19”, said the european executive.
The placing on the market conditional (CMA) is one of the regulatory mechanisms of the EU to facilitate access to medicines that address an unmet medical need”, particularly in “emergency situations in response to public health threats such as the current pandemic”.
According to the EMA, this type of approval “enables to recommend a drug for the authorisation of placing on the market, with data being less complete than expected”, if the benefits outweigh the risks.
Originally developed against the Ebola hemorrhagic fever, this antiviral is the first therapy to have shown a certain effectiveness in patients hospitalized for the COVID-19 in a clinical trial of significant size, even if the effect is considered modest.
The recommendation of the EMA relates to the treatment of the new coronavirus in adults and adolescents from 12 years of age, suffering from pneumonia and need extra oxygen, that is to say, those “with a serious illness”.
In its recommendation last week, the EMA has indicated that a study conducted on more than 1000 patients hospitalized with the COVID-19 has shown that those treated by the remdésivir is recovering, on average, four days faster than other patients.
It has not been proven that the remdésivir avoided the death.