EU Temporarily Authorizes Sale Of Remdesivir To Treat COVID-19 Patients

Antiviral drug remdesivir was authorized by the European Medicines Agency (EMA) on June 25 to be conditionally marketed in 27 European Union (EU) member countries. It was previously approved for emergency usage in severe cases of COVID-19 by the United States, India, South Korea, Singapore and Japan. Now, the EU has joined the bandwagon.  

When there is no medical treatment to handle public health threats, the benefits are weighed in comparison to the risks based on the limited data available. In emergency situations, a conditional authorization for marketing is granted to help meet medical requirements of the public whose lives are at risk. Accordingly, upon a quick assessment of the drug, the Europe’s Committee for Medicinal Products for Human Use (CHMP) recommended to the health care regulator that remdesivir can be used in adults and adolescents older than 12. 

Data was taken from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) before the CHMP submitted the application for market authorization to the EMA on June 5. Over a period of 10 days, 1,000 hospitalized patients were given remdesivir and compared against a placebo treatment. Overall, patients given remdesivir recovered within 11 days, while those who took the placebo recovered in 15 days. However, quicker recovery was limited to severe cases and not seen in mild to moderate cases. 

On the first day of treatment, critically ill patients in dire need of oxygen were intravenously given the drug at a 200-mg infusion limit. Followed by four days of 100-mg infusions a day up to a period of nine days at the maximum. Simultaneously, monitoring kidney and liver function of the patient was done while at the hospital.  

In 2009, Gilead Sciences Inc. headquartered in California manufactured remdesivir to treat hepatitis C. Though it did not work out, eventually, it proved useful in treating the Ebola epidemic in 2018 and was similarly approved for usage as an emergency drug.

A COVID-19 EMA pandemic task force guided the CHMP in arriving at this decision.. The task force was convened to gather expert analysis from medical networks in Europe to develop vaccines and medicines against COVID-19. The EMA provided the European Commission with necessary information to grant conditional marketing authorization, allowing to speed up the process that generally takes years to achieve. 

Moving forward, more reports have to be submitted to the EMA. By August 2020, data on quality and mortality has to be given to the agency. By December 2020, final reports on the effectiveness and safety regarding remdesivir have to be submitted to them. Despite the medicine being available on the market, throughout the year and beyond, studies and post-marketing reports will be evaluated by the CHMP and Europe's Pharmacovigilance Risk Assessment Committee (PRAC).

COVID-19 Coronavirus Drug - Remdesivir Remedesivir has been authorized for conditional marketing in the European Union for severe cases of COVID-19. ULRICH PERREY/POOL/AFP via Getty Images

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