The drugmaker Cipla Ltd on Sunday announced the launch of the experimental end-viral drug Remdesvir under its brand name, Cipramil. Remadecivir is the only FDA-approved Emergency Use Authorization (EUA) treatment for adult or minor patients hospitalized after a suspected or laboratory confirmation of COVID-19 infection.
In May, American drugmaker Gilead Sciences granted Cipla a voluntary non-exclusive license to manufacture and market Cipramil, a generic version of Cipla of Remedisvir.
The company said in a statement that the Drug Controller General of India (DCGI) has given Cipla regulatory approval for limited emergency use in the country as part of an enhanced approval process considering the necessary medical needs.
As part of a risk management plan, Cipla will provide training on the use of this drug, inform the patient’s consent document, conduct post-marketing surveillance as well as to conduct a fourth phase clinical trial on Indian patients.
Cipla Managing Director and Global CEO, Umang Vohra said, “Splia appreciates the strong partnership with Gilead to bring Remedesivir to patients in India. We have invested seriously in exploring all possible measures to save millions of lives affected by the Kovid-19 pandemic, and this launch is an important milestone in this direction. ”
According to the ACTT-1 (Adaptive Covid-19 Treatment Trial 1) study, a randomized clinical trial of Remedisivir at 1,063 patients at more than 60 centers in the US, Europe, and Asia showed that clinical trials of patients hospitalized with this drug The speed of recovery is faster than Placebo.