New Delhi, Jun 22, 2020: Pharma major Cipla Ltd has announced the launch of its generic version of antiviral drug Remdesivir for emergency use in treatment of Covid-19 patients. The new drug will be sold under the brand name Cipremi.
Cipla’s antiviral drug Cipremi is the latest to join Glenmark’s Fabiflu and Hetero’s Covifor to treat Covid-19 patients in the country.
Last week, the Union Health Ministry included the use of antiviral drug Remdesivir as part of “investigational therapy” in India only for restricted emergency-use in its updated Clinical Management Protocol for Covid-19 patients. Off-label application of immunomodulator tocilizumab and convalescent plasma therapy for treating coronavirus patients in moderate stage of criticality, were also approved by the ministry.
Remdesivir, happens to be the only USFDA approved Emergency Use Authorisation (EUA) treatment for adults and children hospitalised with suspected or laboratory confirmed coronavirus infection.
At a time when nearly 200 countries across the globe are grappling with the Covid-19 pandemic, Gilead Sciences Inc extended a voluntary non-exclusive license to India-based Cipla to manufacture and market the generic version of Remdesivir called Cipremi.
The pharma firm 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 medical need with a surge in Covid-19 cases in India, which have crossed the 4,00,000-mark.
Prices of the drug in the Indian market are yet to be announced by Cipla.
“As part of a risk management plan, Cipla will provide training on the use of the drug, inform patients for consent documents, conduct post marketing surveillance as well as conduct a Phase-IV clinical trial on Indian patients,” the company said in a statement.
“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,” MD and Global CEO Umang Vohra said.
So that coronavirus patients can get quick access to this treatment and in anticipation of high demand, Cipla will be commercializing Remdesivir through its own facilities and partnered sites, the company statement said.
The drug will be supplied through the government and open market channels to ensure equitable distribution, the statement read.
On the Bombay Stock Exchange (BSE), shares of Cipla climbed over 9% in Monday’s trade after the pharma major announced the launch of its generic version of Remdesivir.
courtesy: Hindustan Times