Friday, 07 May 2021

DCGI gives EUA to Zydus for using Virafin on COVID-19 patients

23 April 2021 | News

A single dose of the antiviral Virafin administered subcutaneously early on shows significant clinical and virological improvement in moderate COVID-19 adult patients

Image credit- shutterstock.com

Image credit- shutterstock.com

Zydus Cadila ha announced that the company has received Restricted Emergency Use Approval (EUA) 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.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited said “The fact that we are able to offer a therapy which significantly reduces 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.”

In its Phase III clinical trials, the therapy had shown better clinical improvement in the patients suffering from COVID-19. During the trials, a higher proportion of patients administered with PegIFN arm were RT PCR negative by day 7. The drug ensures faster viral clearance and has several add-on advantages compared to other anti-viral agents.

For the development of Virafin, Zydus appreciated the support provided by  DBT-BIRAC COVID-19 Research Consoritum, for conducting the Phase II human clinical trial studies. 

Speaking on this achievement Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, ‘’The government  has been committed to provide 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 which is a boon for the medical facility providers.”

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