Pharma major Cipla on Sunday announced the launch of Remdesivir under the brand name CIPREMI. The United States (US) Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Gilead Sciences for emergency use of Remdesivir for the treatment of COVID-19 patients.
Umang Vohra, MD, Global CEO of Cipla, said, "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."
Gilead Sciences, in May, had extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla's generic version of remedisvir called CIPREMI. Cipla had been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in India.
Vohra added, "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."
Cipla would also provide training on the use of the drug, conduct post-marketing surveillance as well as to conduct a Phase IV clinical trial on the patients in the country.
As per a report from Adaptive COVID-19 Treatment Trial 1 (ACTT-1) study, a clinical trial conducted with Remdesivir in over a thousand patients across US, Europe and Asia demonstrated faster time to recovery in hospitalised patients when compared to a placebo.
Additionally, most of these patients were already on oxygen therapy and some were on a mechanical ventilator. Mortality rates in the research were 7.1 per cent in those given Remdesivir as compared to 11.9 per cent among those with a placebo.
Cipla, to enable speedy and equitable access to this treatment, would be commercialising remdesivir through its facilities and partnered sites. The drug would be supplied through both Government and open market channels.