Bangalore: The Centre said Tuesday it has approved ‘Gilead Sciences Inc’s’ antiviral drug remdesivir for emergency use in treating COVID-19 patients. Remdesivir is the first drug to show improvement in COVID-19 patients in formal clinical trials. It was granted emergency use authorisation by the US Food and Drug Administration last month. Also the drug has received approval by Japanese health regulators.
“(Remdesivir) was approved June 1 under emergency use with condition for five dose administration,” the Drugs Controller General of India (DGCI) said in an email statement. The drug-maker did not immediately respond to an email seeking further details.
As of Tuesday, the country has 198,706 cases of coronavirus and has recorded 5,598 deaths, according to Union Health Ministry data.
‘Gilead Sciences’ had Monday reported that remdesivir showed modest benefit in patients with moderate COVID-19. The benefits were visible after a five-day course. However, those who received it for 10 days in the study did not fare as well.
European and South Korean authorities are also looking at remdesivir. South Korean health authorities last Friday said they would request imports of the drug. Gilead Sciences is yet to gain regulatory approval in either market.
Agencies