CIPREMI 100MG INJECTION
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.