Remdesivir, the only US FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection, is being launched by the Cipla Limited under the brand name Cipremi in India.
In May, US drug maker Gilead Sciences extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir 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.
‘Remdesivir’s safety and efficacy on humans is analysed using a clinical trial on 1,063 patients across US, Europe and Asia. It demonstrated a faster time to recovery in hospitalised patients with COVID-19.’
As part of a risk management plan, Cipla will provide training on use of the drug, inform patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients.
“Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by Covid-19 pandemic, and this launch is a significant milestone in that direction,” said Umang Vohra MD and Global CEO, Cipla.
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 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 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.