An antiviral used to treat Ebola is the first drug to get the green light from the EU's medicines agency to treat Covid-19 patients.
On Thursday, the European Medicines Agency (EMA) said that it recommended using the drug remdesivir to treat Covid-19 patients over the age of 12 with pneumonia and requiring oxygen therapy.
The agency said that it recommended giving conditional market authorisation to the drug, a procedure used to speed up the approval of a drug which can address "unmet medical needs."
Related News
- Coronavirus: WHO warns of surge of new cases in Europe
- Life-saving coronavirus drug 'promising' for Belgium, state virologist says
- Belgium begins clinical trial on coronavirus treatments
Conditional approval is given without the bulk of comprehensive data that is usually required, but only if the data that is available can prove that the drug's benefits outweigh its potential risks.
The agency said that in this case, it based its recommendation on a US-sponsored study which showed that the use of remdesivir sped-up the recovery of Covid-19 patients with serious symptoms of the disease.
The EMA said that the study did not provide evidence that the use of the antiviral was beneficial to patients with mild to moderate Covid-19 symptoms, after those who took the drug took the same time to recover as those who were given a placebo.
In an online statement, the agency said that the results of the study showed that the drug was beneficial to patients with severe Covid-19, those who had developed pneumonia and needed oxygen therapy.
The EMA said that the EU Commission would decide on whether to grant the drug the conditional market authorisation within a week.
The antiviral has already received approval for emergency use in the US and the UK has also approved it for limited use.
Gabriela Galindo
The Brussels Times
