Doctors in Cyprus will soon be able to treat COVID-19 patients with the antiviral drug, remdesivir, after the European Medicines Agency’s (EMA) endorsement put it on track to be the first therapy for the disease.
The Cyprus Health Ministry endorsed the drug on Friday.
The European Medicines Agency (EMA) said on Thursday its human medicines committee (CHMP) recommended conditionally approving the drug for adults and adolescents from 12 years of age who are also suffering from pneumonia and require oxygen support.
According to the Health Ministry, remdesivir is the first medicine against COVID-19 to be recommended for authorisation in the EU.
Remdesivir has been approved for emergency use in severely ill patients in the United States, India and South Korea, and has received full approval in Japan.
“Data on remdesivir was assessed in an exceptionally short timeframe through a rolling review procedure, an approach used by EMA during public health emergencies to assess data as they become available,” said the Health Ministry statement.
From 30 April 2020, the CHMP began assessing data on quality and manufacturing, non-clinical data, preliminary clinical data and supporting safety data from compassionate use programmes, well in advance of the submission of the marketing authorisation application on 8 June.
The assessment of the dossier has now concluded with the recommendation, which is mainly based on data from study NIAID-ACTT-1, sponsored by the US National Institute of Allergy and Infectious Diseases.
Overall, the study showed that patients treated with remdesivir recovered after about 11 days, compared with 15 days for patients given a placebo.
This effect was not observed in patients with mild to moderate disease: time to recovery was 5 days for both the remdesivir group and the placebo group.
For patients with severe disease, who constituted approximately 90% of the study population, time to recovery was 12 days in the remdesivir group and 18 days in the placebo group.
However, no difference was seen in time to recovery in patients who started remdesivir when they were already on mechanical ventilation or ECMO (extracorporeal membrane oxygenation).
Data on the proportion of patients who died up to 28 days after starting treatment are currently being collected for final analysis.
Taking into consideration the available data, the Agency considered that the balance of benefits and risks had been shown to be positive in patients with pneumonia requiring supplemental oxygen.
The drug’s European price is not yet known, but reportedly, the United States, a research group suggests remdesivir can be priced at up to $5,080 per course, while Indian generic drugmakers are to sell the treatment for 5,000 rupees to 6,000 rupees ($66.13-$79.35).