Cipla launches generic remdesivir ‘Cipremi’ for COVID-19 pat
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Cipla Limited, on 21st June 2020, announced the launch of remdesivir under its brand name CIPREMI.

• The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of adult and pediatric patients hospitalized with suspected or laboratory-confirmed COVID-19 infection.

• In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir called CIPREMI.

• Cipla has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country.

• As part of a risk management plan, Cipla will conduct post-marketing surveillance as well as to conduct a Phase IV clinical trial on Indian patients.

• According to a preliminary report from a randomized clinical trial conducted with remdesivir in 1063 patients over 60 centres across U.S., Europe, and Asia demonstrated faster time to clinical recovery in hospitalized patients as compared to placebo.

• Most of these patients were on oxygen therapy of which some were receiving high flow oxygen or non-invasive ventilation, and some were on a mechanical ventilator. The mortality rates in the study were 7.1% in those given remdesivir and 11.9% in those who were given a placebo.

• The drug will be supplied through Government and open market channels, to ensure equitable distribution.

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