India’s Dr. Reddy Denied Full Approval for Remdesivir
An expert panel of India’s drug regulatory authority has recommended against granting a request by Dr. Reddy’s Laboratories for a full approval of the COVID-19 antiviral remdesivir in that country.
India’s Central Drugs Standard Control Organization said it will keep the drug’s status as “restricted emergency use.” The decision follows a study by the World Health Organization, which found no clinical benefit or improvement in survival outcomes for COVID-19 patients in a review of multiple remdesivir trials.
Dr. Reddy’s is one of seven companies that Gilead Sciences granted nonexclusive, royalty-free licenses to to produce remdesivir during the pandemic.
In contrast to India’s health regulator, the FDA granted remdesivir full approval in October as a treatment for the coronavirus.