The Drugs Controller General of India (DGCI) on Friday granted restricted emergency use approval to Zydus Cadila’s anti-COVID-19 drug ‘Virafin.’ Virafin, or Pegylated Interferon alpha-2b (PegIFN), will be used for treating moderate COVID-19 infection in adults. A release by Zydus states that a single dose of the antiviral drug Virafin will make the treatment more convenient for the patients, and that it reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate COVID-19 patients.
When administered early on for COVID-19 infections, Virafin will help patients recover faster and avoid many COVID-19-related complications. Virafin will be available only on the prescription of a medical specialist for use in a hospital or an institutional setup, the release said.
Zydus has said that in its Phase-III clinical trials, the drug had shown better clinical improvement in the patients suffering from COVID-19. During the trials, a higher proportion of patients — 91.15% — who were administered with PegIFN, were RT-PCR negative by day seven. The drug ensures faster viral clearance and has several add-on advantages compared to other anti-viral agents.
Zydus added that in the multicentric trial conducted in 20 to 25 centres across India, Virafin had shown a lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating COVID-19. The drug has also shown efficacy against other viral infections, the release said.
Earlier this month, on April 5, Zydus had sought DCGI approval for the use of Virafin for the treatment of COVID-19 symptoms.
Speaking on the DCGI granting emergency use approval for Virafin, Dr Sharvil Patel, Managing Director, Cadila Healthcare Limited said, “The fact that we are able to offer a therapy which significantly reduces the viral load when given early on can help in better disease management. It comes at a much-needed time for patients and we will continue to provide them access to critical therapies in this battle against COVID-19.”