Cipla announced the launch of remdesivir under its brand name CIPREMI. The USFDA issued an Emergency Use Authorization (EUA) to Gilead Sciences for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (Covid-19) patients. It is the only USFDA approved Emergency Use Authorization (EUA) treatment for adult and pediatric patients hospitalized with suspected or laboratory-confirmed Covid-19 infection. In May, Gilead Sciences 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-market surveillance, and 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 in 1063 patients over 60 centers across the US, Europe, and Asia demonstrated faster time to clinical recovery in hospitalized 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 that given remdesivir and 11.9% in those who were given the placebo.
As part of its efforts to enable speedy and equitable access to this treatment and in anticipation of demand, Cipla will be commercializing remdesivir through its facilities and partnered sites. The drug will be supplied through Government and open market channels to ensure equitable distribution.
Commenting on the launch, Umang Vohra, managing director, and chief executive officer, Cipla said, “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 the Covid-19 pandemic, and this launch is a significant milestone in that direction. We will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with our belief that no patient should be denied access to life-saving treatments.”