Zydus’s `Virafin’ gets emergency use approval from DGCI for treatment of Covid patients
23 Apr 2021
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The Drug Controller General of India (DCGI) has granted Restricted Emergency Use Approval for Zydus Cadila’s Pegylated Interferon alpha-2b (PegIFN) or `Virafin’ for 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, the company stated in a release.
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.
“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,” Dr Sharvil Patel, managing director, Cadila Healthcare Limited, said.
In 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.
Type I interferons are body’s first line of defence 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.
Zydus has been backed by the Biotechnology Industry Research Assistance Council (BIRAC), the industry collaboration arm of the Department of Biotechnology, in the development of Virafin.
The development comes at a time when India's daily Covid tally is crossing the 3-lakh mark. India has reported over 3 lakh new Covid-19 cases in a single day. India has recorded 3,32,730 new cases in the last 24 hours, also the world's highest rise in the cases in a day, as per the union health ministry.
The total number of cases stood at 1,62,63,695 and active cases crossed the 2.4-million mark, the data updated at 8 am showed. The death toll rose to 1,86,920 as 2,263 fatalities, another single-day record, were reported in the last 24 hours, the data said.
