The antiviral remdesivir is on track to be marketed in Europe to treat patients with Covid-19. The European Medicines Agency (EMA) recommended Thursday, June 25, the authorization of a "conditional marketing" of this drug within the European Union for serious patients, in response to the "situation of emergency "created by the coronavirus pandemic. "Remdesivir is the first Covid-19 drug to be recommended for authorization in the EU," the Amsterdam-based agency said in a statement.

Modest effect

The conditional marketing authorization for this antiviral must now be approved or not by the European Commission, which "aims to make a decision in the coming week", according to the EMA.

Initially developed for Ebola hemorrhagic fever, remdesivir is the first therapy to have shown some efficacy in patients hospitalized for Covid-19 in a clinical trial of significant size, even if the effect is considered to be modest.

The EMA recommendation concerns the treatment of the new coronavirus in adults and adolescents from 12 years of age, suffering from pneumonia and needing additional oxygen, ie those "suffering from a serious illness".

"Given the available data", the agency considered that the positive effects of the drug outweigh the risks for this type of patient.

A study carried out on more than 1,000 hospital patients with Covid-19 has shown that those treated with remdesivir recover on average four days faster than other patients, says the EMA.

"This effect has not been seen in patients with mild to moderate illness," the agency said.

"Rigorous security check"

In the United States, the Medicines Agency (FDA) authorized the emergency use of remdesivir in hospitals on May 1, followed by Japan, while Europe is considering a similar decision.

Conditional placing on the market (CMA) is one of the EU's regulatory mechanisms to facilitate access to medicines "which meet an unmet medical need", particularly in "emergency situations in response threats to public health such as the current pandemic, "says the EMA.

According to the agency, this type of approval "allows it to recommend a drug for marketing authorization with less complete data than expected, if the benefit of the immediate availability of a drug for patients outweighs the risk inherent in the fact that not all data are available yet. "

As with all medicines, a risk management plan "will ensure strict safety control of remdesivir", developed by the American laboratory Gilead, if it is authorized in the EU, she said.

"In order to better characterize the efficacy and safety of remdesivir, the company will have to submit the final studies reports" on this drug to the agency by December 2020, as well as "additional data on the quality of the drug and final mortality data by August 2020, "warned the EMA.

Other data will also be collected through ongoing studies. The EMA has also recently announced the establishment of independent research in order to prepare for the surveillance of possible vaccines against Covid-19 before and after their placing on the European market.

With AFP

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