Remdesivir Recommended for EU Authorization as First COVID-19 Treatment
Key Insights
The European Medicines Agency (search) (EMA) has recommended Remdesivir for authorization in the EU, marking it as the first COVID-19 (search) treatment to receive such a recommendation.
The CHMP recommends Remdesivir be used in adults and adolescents (12+) with pneumonia requiring supplemental oxygen.
A study showed Remdesivir-treated patients recovered in 11 days versus 15 days with a placebo, a 31% faster recovery.
The European Medicines Agency (search) (EMA) has recommended the antiviral drug Remdesivir for authorization in the European Union to treat patients with COVID-19 (search). This marks Remdesivir as the first medicine for COVID-19 to be recommended for authorization in the EU.
The EMA's Committee for Human Medicines (CHMP) has suggested the drug be used on adults and adolescents aged 12 and over who are suffering from pneumonia and require supplemental oxygen.
Clinical Trial Results
Clinical data supporting the recommendation comes from a study indicating that patients treated with Remdesivir experienced a notably faster recovery. Specifically, coronavirus patients treated with Remdesivir recovered in 11 days, compared to 15 days for those who received a placebo. This represents a 31 percent faster recovery time for the treatment group. The study, sponsored by the U.S. National Institutes of Health, commenced in February and involved 1,063 patients across the U.S., Europe, and Asia.
Mechanism of Action
Remdesivir functions by interfering with an enzyme critical for RNA virus replication. Laboratory studies have demonstrated its effectiveness against coronaviruses. The drug was originally developed to treat Ebola (search) during the outbreak in West Africa.
Context
Remdesivir has been mentioned by health officials as one of the most promising drugs to fight COVID-19 (search).