EMA Reviewing Remdesivir for COVID-19 Patients Who Don’t Require Supplemental Oxygen
The European Medicines Agency (EMA) is evaluating remdesivir data submitted by Gilead Sciences to determine whether the antiviral’s indication should be expanded to cover adult COVID-19 patients who don’t need supplemental oxygen.
The agency’s recommendation, which it expects to provide before the summer, would need to be accepted by the European Commission, which will have the final say in authorizing or rejecting the proposed expanded indication. The authorization would allow the drug to be used more widely in the EU for treating COVID-19 at a time when European countries face shortages of and delays in getting vaccine supplies.
The data are being assessed by the EMA’s Committee for Medicinal Products for Human Use (CHMP). The drug was granted conditional marketing authorization in the EU in July 2020 for treating COVID-19 in adults and adolescents with pneumonia who require supplemental oxygen. The EMA explained at the time that although there were less data than it would normally expect, the drug’s benefits appeared to outweigh its risks.
Recently, the agency’s drug safety committee concluded that remdesivir was not associated with acute kidney injuries in COVID-19 patients after reviewing all available information, including clinical trial data, scientific literature and adverse reaction reports. The committee had opened its review after patients given the drug reported kidney problems, raising concerns that remdesivir could cause serious kidney injuries.
Remdesivir is still mired in controversy as a COVID-19 treatment. Though it’s been approved by the FDA for treating COVID-19 patients 12 years and older who require hospitalization, the World Health Organization has argued against its use in hospitalized patients. The organization found in November 2020 that there was no evidence showing it helped survival, time to clinical improvement, need for mechanical ventilation or other outcomes, a conclusion that Gilead has strongly disputed (DID, Nov. 23, 2020). — James Miessler