The government said on Tuesday it has approved emergency use of remdesivir, a Gilead Sciences Inc’s antiviral drug 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 authorization by the US Food and Drug Administration last month and has received approval by Japanese health regulators.
Drug Controller General of India VG Somani has approved the use of Gilead Sciences Inc’s novel drug remdesivir to treat COVID-19 patients, Lav Aggarwal, joint secretary in the health ministry, said on Tuesday.
“The DCGI gave permission for emergency use of remdesivir… and this was based on evidence that was provided by the company to support its use against COVID-19,” Aggarwal said at a press conference.
Aggarwal said further details on the protocols for use of the intravenous drug will be provided by the government in due course.
Gilead Sciences had on Monday reported that remdesivir showed modest benefit in patients with moderate Covid-19 given a five-day course, while 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, with South Korean health authorities last Friday saying they would request imports of the drug. Gilead is yet to gain regulatory approval in either market.
In India, Gilead has given voluntary license for production of remdesivir to Cipla, Jubilant Life Sciences, Hetero Drugs and Mylan under a royalty-free arrangement till an alternative drug is found or until the World Health Organization removes the designation of ‘Public Health Emergency of International Concern’ for the COVID-19 pandemic.
Gilead’s remdesivir was earlier under trial for Ebola, but the drug could not pass clinical trials. However, the COVID-19 pandemic has given a fresh life to the drug, which experts have said is complex to manufacture.
Mean-while, India’s COVID-19 count inched closer to the grim milestone of 2 lakh-mark. The states registered over 8,000 fresh cases for the third straight day. The total number of coronavirus patients in India rose to 198,706.
Maharashtra continued to report the highest fresh cases while Tamil Nadu witnessed the biggest spike on Monday. However, the number of fresh coronavirus cases dipped slightly in the national capital.