The EU’s medicines regulator has launched a safety review of a drug used to treat COVID-19 following reports of serious kidney problems in some patients.
The drug, remdesivir, was authorised in the European Union for treatment in patients severe forms of COVID-19 who need oxygen treatment.
The European Medicines Agency (EMA) said on Friday it was not yet determined whether the drug caused kidney injury in patients who reported kidney problems as kidney injury is also a potential complication of severe forms of COVID-19.
The EU’s risk management plan for remdesivir, released in June, highlighted kidney problems as a potential risk of the drug, primarily due to testing in rats and monkeys.
The medicines agency said the new reports constituted a “safety signal”, a potential adverse effect caused by a medicine that warrants review.
Remdesivir was originally authorised in the EU after it “showed a clinically meaningful effect on time to recovery in COVID-19 patients…while being well tolerated with mild side effects,” the EMA said.
The EMA had concluded that the “benefits are greater than its risks”.
The EU signed a €63 million deal to secure 30,000 doses of the treatment after it had been found to reduce recovery time for hospitalised COVID-19 patients — those with the most severe infections — from 15 to 11 days.
The drug is designed to interfere with an enzyme the virus uses to copy its genetic material.
