European Medicines Agency recommends remdesivir to treat coronavirus

The European Medicines Agency (EMA) has recommended this Thursday, for the first time since the beginning of the pandemic, to authorise the marketing of a drug known as Veklury (Remdesivir) for the treatment of COVID-19 in adults and adolescents over 12 years of age with pneumonia. Remdesivir is an antiviral that slows down the production of new virus particles and, as a result, a viral infection develops less quickly and patients in severe condition recover on average four days earlier than usual.

Although the latest decision is still in the hands of the European Commission, this is the first drug to pass the evaluation by the Amsterdam-based medical agency, which was done "in an exceptionally short period through a continuous review procedure", given the public health emergency posed by the coronavirus.

The "conditional" authorisation by the EMA to sell a drug means that it can be marketed with slightly less data available and before the usual time it takes to authorise a drug under normal conditions, facilitating rapid access to the product in contexts such as a pandemic. This emergency process is only followed if the benefit of immediate availability of a drug to patients outweighs the risk inherent in the fact that not all data are yet available.

This was done even more quickly than expected because the quality, non-clinical and preliminary clinical data, together with the safety of this drug, began to be studied by this agency's committee on human medicines on 30 April, before the application for authorisation for sale in the EU by Veklury, which arrived on 5 June, was submitted to the EMA.

Remdesivir, an experimental therapy that began development in 2009 and was tested on Ebola patients in the mid-1990s, has been authorised for the SARS-CoV-2 coronavirus because a US clinical trial showed that the drug shortens recovery time in some patients. Evaluation of the drug as a possible treatment for COVID-19 in the EU was completed Thursday, based primarily on that U.S. National Institute of Allergy and Infectious Diseases (Niaid) study of more than 1,000 critical patients in 75 hospitals in different countries, and compared its effect with a placebo and the average time it takes a patient to recover from COVID-19.

Hospitalized patients taking Remdesivir recovered an average of 31 percent faster than those taking a placebo, while the average recovery period was reduced from 15 days to 11 days. Other studies indicate that its effectiveness against the new coronavirus is unclear. Taking into account the available data, the agency considered that the balance between benefits and risks had been shown to be positive in patients with pneumonia requiring respirators, patients with severe illness, and therefore chose to authorize it, the agency said.

The European Commission is expected to give the green light to the drug next week and it will be available for sale in the EU under the name of Veklury for a period of one year. However, it is not yet clear how many doses of Remdesivir will be available for the European market, which will have to be negotiated with the US producer Gilead Sciences.