Drug Controller General of India V.G. 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.
“The DCGI gave an emergency use permission for remdesivir… and this was based on evidence that was provided by the company to support its use against covid-19,” Aggawal 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.
In India, Gilead has given voluntary licence 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.
In August, the trials for the drug against Ebola were stopped. However, the covid-19 pandemic has given a fresh life to the drug, which experts have said is complex to manufacture.
Gilead Sciences Inc late Monday said that results from its phase 3 clinical trial in hospitalized patients with moderate covid-19 pneumonia showed that a five-day treatment course of remdesivir resulted in significantly greater clinical improvement as compared to standard care alone.
The odds of improvement in clinical status with the 10-day treatment course also favourable compared to standard of care were but were not of statistical significance as against a five-day course, it said.
Two earlier trials–the National Institute of Allergy and Infectious Diseases’ (NIAID) placebo-controlled study and Gilead’s own study on severe patients—had shown that 5 days of remdesivir treatment led to significantly clinical improvement among patients by reducing the time to recovery.
The NIAID study was also peer-reviewed and published in The New England Journal of Medicine last month.