Domestic drug major Cipla announced the launch of a generic version of remdesivir under its brand name CIPREMI.
Remdesivir is a broad-spectrum antiviral medication developed by the biopharmaceutical company Gilead Sciences. It is administered via injection into a vein.
The US FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalised COVID-19 patients.
It is the only US FDA approved EUA treatment for adult and paediatric patients hospitalised 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.
In a press release filed with exchanges on Sunday, Cipla said, it 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, inform patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients.
As part of its efforts to enable speedy and equitable access to this treatment and in anticipation of demand, Cipla 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, the release added.
“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,” Umang Vohra, MD and Global CEO, Cipla Limited was quoted in the statement.
“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,” he added.