Cipla launches Remdesivir under its brand name CIPREMI
Cipla Limited today announced the launch of Remdesivir under its brand name CIPREMI.
United States Food and Drug Administration (USFDA) issued an emergency use authorisation (EUA) to Gilead Sciences Inc. for emergency use of the drug for the treatment of COVID-19 patients.
Earlier in May, Gilead Sciences Inc. granted Cipla an extension of voluntary non-exclusive license to manufacture and market Cipla’s generic version of Remedisvir. Under Federal Food, Drug and Cosmetic Act (FD&C Act), FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency situation, when there are no adequate, approved and available alternatives. USA has more than 20 lakh confirmed Coronavirus cases with around 1.2 lakh deaths in the country.
A randomised clinical trial conducted with Remdesivir in patients across US, Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo. The mortality rates in the study were also lower in those given Remdesivir as compared to those who were given placebo. Many pharmaceutical trails are conducted across the world, using various drugs to test the effectiveness of the drug in fighting Coronavirus.
In India, Cipla has even been granted regulatory approval by Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgency of the situation. Remdesivir will be commercialised through Cipla’s own facilities and partnered sites. To ensure equitable distribution, the drug will be supplied through government and open market channels.
Cipla stock opened at 696, up by 9.24 per cent or Rs 58.9 per share from its previous day's close.