The European Medicines Agency (EMA) on Thursday recommended the approval of a “conditional marketing” of the European Union antiviral remedy for patients affected by the new coronavirus.
The antiviral strap desivir is about to be marketed in Europe to treat patients with Covid-19. The European Medicines Agency (EMA) on Thursday, June 25, recommended the approval of a “conditional marketing” of this drug in the European Union for serious patients, in response to the “emergency situation” created by the coronavirus pandemic. “Remdesivir is the first Covid-19 drug recommended for approval in the EU,” the Amsterdam-based agency said in a statement.
The conditional marketing authorization for this antiviral must now or may not be approved by the European Commission, which “aims to make a decision in the coming week”, according to the EMA.
Originally developed for ebola-hemorrhagic fever, remdesivir is the first treatment that has shown some effect in patients admitted to Covid-19 in a significant clinical trial, although the effect is considered modest.
The EMA Recommendation refers to the treatment of the new coronavirus in adults and adolescents 12 years old who suffer from pneumonia and need an oxygen supplement, ie those who “suffer from a serious illness”.
“Given the available data,” the Agency considered that the positive effects of the drug outweigh the risks to this type of patient.
A study conducted 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, EMA says.
“This effect has not been seen in patients with mild to moderate illness,” the agency says.
“Rigorous security check”
In the US, the Medicines Agency (FDA) has approved 1your Japan can follow the urgent use of remedies in hospitals, while Europe is considering a similar decision.
Conditional Market Release (CMA) is one of the EU regulatory mechanisms to facilitate access to medicines “that meet an unmet medical need”, especially in “emergency health response threats to the current pandemic,” the EMA says.
According to the agency, this type of approval allows it to recommend a marketing authorization drug with less complete data than expected, if the benefit of immediate availability of a drug to patients outweighs the risk inherent in the fact that not all data is available yet. “
As with all drugs, a risk management plan “will ensure strict safety control of remedies,” developed by the US laboratory Gilead, if approved in the EU, she said.
“To better characterize the efficacy and safety of remdesivir, the company must submit the final study reports” on this drug to the Agency by December 2020, as well as “additional data on the drug’s quality and final mortality data in August 2020,” EMA warned.
Other data will also be collected through ongoing studies. EMA has also recently announced the establishment of independent research to prepare for the monitoring of potential vaccines against LeCovid-19 before and after their release on the European market.