Zydus gets approval from DCGI for use of Virafin in treating moderate COVID-19 infection in adults
Ahmedabad, April 23, 2021
Pharmaceuticals major Zydus Cadila today announced that it 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," a press release from the company said.
The release said Virafin will be available on the prescription of medical specialist for use in hospital/institutional setup.
According to the release, in the multicentric trial conducted in 20-25 centres 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.
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, the release said.
"Type I interferons are body’s first line of defense against many viral infections and Pegylated Interferon alpha-2b has been used to treat these infections successfully. Interferon alpha has also been implicated as crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science.
"Furthermore, aging reduces the body's ability to produce Interferon Alpha in response to viral infections and may be associated with the higher mortality observed with COVID-19 in elderly patients. Virafin when given early on during infection can replace this deficiency and aid a faster recovery process," it said.
Zydus acknowledged the support of Biotechnology Industry Research Assistance Council (BIRAC), set up by Department of Biotechnology (DBT), Government of India as an Interface Agency, in the development of Virafin for the treatment of COVID-19.