The only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for Covid patients
Cipla Limited, hereinafter referred to as “Cipla”), today announced the launch of remdesivir under its brand name CIPREMI. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients. It is the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir called CIPREMI.
Cipla has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need. As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients.
According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study1, a randomized clinical trial conducted with remdesivir in 1063 patients over 60 centres across U.S., Europe and Asia demonstrated a 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% in those given remdesivir and 11.9% in those who were given placebo.
