The conditional marketing authorisation for remdesivir was granted under the accelerated review process considering the emergency situation and unmet medical needs
Indian drug regulator -- Central Drugs Standard Control Organisation (CSDSCO) -- on June 1 granted conditional approval to Gilead Sciences to market investigational drug remdesivir, sources told Moneycontrol.
The conditional marketing authorisation for remdesivir was granted under accelerated review process, considering the emergency situation and unmet medical needs in light of the novel coronavirus, or COVID-19 pandemic. The drug approval is for restricted emergency use in the country. The regulator said the approval was granted after consultation with a subject expert committee.
Gilead was granted a clinical trial waiver for remdesivir so that the medicine can be made available to patients faster.
A Gilead's spokesperson was not available immeditely for comment.
The marketing authorisation for remdesivir was filed in India by clinical research organisation (CRO) KlinEra, on behalf of Gilead Sciences last week. Remdesivir is currently approved in Japan as a treatment for patients infected with SARS-CoV-2, the virus that causes COVID-19. The US Food & Drug Administration (USFDA) granted remdesivir an emergency use authorisation for treatment of hospitalised patients with severe COVID-19.
The approval comes in the backdrop of two Indian pharmaceutical companies Cipla and Hetero Labs having sought permission from drug regulator to manufacture and sell remdesivir in India.
Gilead had entered into non-exclusive voluntary licensing agreements with five generic pharmaceutical companies, including Cipla, Jubilant Life Sciences and Hetero, for manufacture and distribution of remdesivir.
Gilead on June 1 announced latest data on remdesivir from its phase-3 SIMPLE trial that demonstrated moderate COVID-19 pneumonia patients taking five-day treatment course of the anti-viral drug are 65 percent more likely to show signs of clinical improvement by Day 11 compared with those in the standard care group. However, the drug given for 10-day treatment course was favourable compared to the standard care group, but hasn't been statistically significant.
Gilead said no new safety signals were identified with remdesivir across either treatment group. It plans to submit the full data for publication in a peer-reviewed journal in coming weeks.The previously released data from a similarly-run open-label Phase 3 trial evaluating remdesivir in severely ill COVID-19 patients, as well as another Phase 3 trial run by the National Institute of Allergy and Infectious Diseases (NIAID), found the drug could reduce the time to recovery in severely ill patients.