Zydus Cadila’s ‘Virafin’ received restricted emergency use approval for COVID treatment
Drug Controller General Of India (DCGI) gave a restricted emergency use approval to Zydus Cadila’s ‘Virafin’ for treating the patients showing moderate COVID-19 symptoms. Virafin is a pegylated interferon alpha-2b(PegIFN), which when subcutaneously injected to the patient in the early stages of infection, resulted in their faster recovery.
For the development of Virafin, Zydus appreciated the support provided by DBT-BIRAC COVID 19 Research Consortium through NBM, for conducting the Phase II human clinical trial studies. The studies confirmed the safety, tolerability and efficacy of Virafin. The studies also reported that Viarfin reduces viral load and aid in managing the disease in a better way, such as reduction in the need for supplemental oxygen, thereby reducing the respiratory tension caused due to low oxygen levels.
Speaking on this occasion, Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said,
‘’The government has been committed to providing all possible facilitation to our industries to work towards mitigation strategies and interventions against COVID-19 pandemic. The emergency nod provided to Virafin is another milestone that is a boon for the medical facility providers. I highly appreciate the efforts put in for this achievement.”
Managing Director of Cadila Healthcare Limited, Dr Sharvil Patel added:
“The realisation that we can to provide a therapy that reduces viral load substantially when given early and can aid in better disease management. It comes at a critical time for patients, and we will continue to give them access to the critical therapies as we together fight against COVID-19.”
Phase III clinical trial studies reported that a larger proportion of patients when administered subcutaneously with Virafin turned out to be RT-PCR negative by day 7, apart from faster recovery as compared to other anti-viral agents.