The European Medicines Agency (EMA) recommended granting conditional approval for the sale of Veklury (Remdesivir, Remdesivir), which can be used to treat adults and adolescents over 12 years old with a diagnosis of pneumonia and positive tests for COVID-19 coronavirus. This was reported by the press service of the agency.
Remdesivir is the first anti-COVID-19 drug recommended for EU approval, ”the report said.
Conditional sales authorization is one of the EU regulatory mechanisms to facilitate early access to medicines that meet unmet medical needs, including in emergency situations, such as the COVID-19 coronavirus pandemic. This type of approval allows EMA to recommend a drug for sale authorization, even if there is less evidence of its effect than is usually required. This is done if the benefit of its immediate availability to patients exceeds the risk associated with the fact that not all data on it is yet available.
The agency said that the EMA committee for medicines for humans began evaluating the quality and production of Remdesivir from April 30, long before the manufacturer submitted an application for a sales permit (June 5).