The agency will communicate its decision on whether or not to extend the indication of this antiviral “before the summer”.
The European Medicines Agency (EMA) has begun evaluating an application from Gilead to include treatment with remdesivirof adults with Covid-19 who do not require supplemental oxygen.
Remdesivir is currently authorized for use in adults and adolescents (12 years of age and weighing at least 40 kilograms) with pneumonia who require supplemental oxygen (low- or high-flow oxygen or other non-invasive ventilation at the start of treatment). ).
The EMA’s Committee for Medicinal Products for Human Use (CHMP) will evaluate the data presented by the pharmaceutical company and recommend whether or not the extension of the indication should be authorized.
The EMA will communicate the result of the evaluation “before the summer”, as reported by the European regulatory body through a statement. It should be remembered that Gilead’s antiviral was authorized in the European Union last July.
The active substance, remdesivir, is a RNA polymerase inhibitor virus that interferes with the production of viral RNA (genetic material), preventing the SARS-CoV-2 virus from multiplying inside cells.