Drugmaker Cipla Limited on Sunday, 21 June announced the launch of experimental anti-viral drug remdesivir under its brand name Cipremi. Remdesivir is the only US FDA approved Emergency Use Authorisation (EUA) treatment for adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19 infection.
In May, US drugmaker Gilead Sciences extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remdesivir called Cipremi.
The Drug Controller General of India (DCGI) has granted Cipla regulatory approval for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need, the company said in a statement.
As part of a risk management plan, Cipla will provide training on the use of the drug, inform patient consent documents, conduct post-marketing surveillance as well as to conduct a Phase IV clinical trial on Indian patients.
According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study, a randomized clinical trial conducted with remdesivir on 1,063 patients over 60 centres across US, Europe and Asia demonstrated faster time to clinical recovery in hospitalised patients as compared to placebo.
Most of these patients were on oxygen therapy of which some were receiving high flow oxygen or non-invasive ventilation, and some were on a mechanical ventilator.
The mortality rates in the study were 7.1 per cent in those given remdesivir and 11.9 per cent in those who were given placebo.
In May, Gilead Sciences signed non-exclusive voluntary licensing agreements with six Indian pharmaceutical companies to boost the supply of remdesivir, the experimental antiviral drug that has shown promise in COVID-19 treatment.
These companies were -- Dr. Reddy's Laboratories Ltd., Zydus Cadila Healthcare Ltd., Biocon company Syngene, Hetero Labs Ltd.; Jubilant Lifesciences; and Cipla Ltd.
Media reports said that Hetero Labs Ltd has also received regulatory approval from DCGI but the drug maker was yet to make it official.
Cipla said it will be commercialising remdesivir through its own facilities and partnered sites.
The drug will be supplied through government and open market channels, to ensure equitable distribution.