DCGI (India) grants emergency use approval for Pegylated Interferon alpha-2b, ‘Virafin’ in treating moderate COVID-19 infection in adults.- Zydus Cadilla

Zydus Cadila announced that the company has received Restricted Emergency Use Approval from the Drug Controller General of India (DCGI) for the use of Virafin, Pegylated Interferon alpha-2b (PegIFN) in treating moderate COVID-19 infection in adults. A single dose subcutaneous regimen of the antiviral Virafin will make the treatment more convenient for the patients. When administered early on during COVID, Virafin will help patients recover faster and avoid much of the complications. Virafin will be available on the prescription of medical specialist for use in hospital/institutional setup. In the multicentric trial conducted in 20-25 centers across India, Virafin had shown 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. Phase III clinical trial data : The Phase III trials demonstrated that a higher proportion of patients in the PegIFN arm showed a two point statistically significant clinical improvement (WHO 7-point ORDINAL SCALE) on day 8 as compared to the Standard of Care (SOC arm) (80.36% vs 68.18%). Clinically the hours of supplemental oxygen required was significantly lesser in the PegIFN arm and as well as the time to resolution of signs and symptoms as compared to the SOC arm (5 days vs 6 days). The findings are in line with recently reported importance of early IFN treatment in the treatment of COVID-19 .