Indian drugmaker Cipla has introduced the generic version of remdesivir, dubbed Cipremi, to treat patients with severe Covid-19 disease.
In May, Gilead Sciences secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its remdesivir to treat of hospitalised Covid-19 patients.
Remdesivir is claimed to be the only US FDA approved EUA treatment for adult and paediatric patients hospitalized with suspected or laboratory-confirmed Covid-19 infection.
During the same month, Gilead expanded a voluntary non-exclusive licence to Cipla to manufacture and sell its generic version of remedisvir under Cipremi brand.
Cipla has secured approval from the Drug Controller General of India (DCGI) for restricted emergency use of Cipremi under accelerated approval process to meet the current medical requirements.
Cipla stated that it will offer training on the use of the drug, informed patient consent documents, conduct post-marketing surveillance and carry out a phase IV clinical trial on Indian patients.
A randomised clinical study showed a faster time to clinical recovery in hospitalised patients as compared to placebo, as per the preliminary report of the ACTT-1 (Adaptive Covid-19 Treatment Trial 1) study.
Cipla intends to commercialise remdesivir through its own facilities and partnered sites for rapid distribution of the treatment to the patients. It will be supplied via government and open market channels.
Cipla global CEO and MD Umang Vohra 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 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.”
Separately, the Indian Central Drugs Standard Control Organisation (CDSCO) approved the use of Glenmark Pharmaceuticals’ generic for Favipiravir and Cipla and Hetero Drugs’ respective generics for Remdesivir for the treatment of Covid-19 patients.