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Zydus Cadila's Virafin gets DGCI approval for treating moderate Covid infection in adults

Drugs Controller General of India (DGCI) has approved emergency use for Zydus Cadila's Pegylated Interferon alpha-2b, 'Virafin' for treating moderate COVID-19 infection in adults.

India TV News Desk India TV News Desk
New Delhi Updated on: April 24, 2021 0:06 IST
A health worker prepares to administer the COVAXIN vaccine
Image Source : AP

A health worker prepares to administer the COVAXIN vaccine for COVID-19 to a man at an indoor stadium. (Representational image)

Drugs Controller General of India (DGCI) has approved emergency use for Zydus Cadila's Pegylated Interferon alpha-2b, 'Virafin' for treating moderate COVID-19 infection in adults.

Earlier, Zydus Cadila announced that its Phase III clinical trials with Pegylated Interferon Alpha 2b, PegiHep has shown promising results in treating Covid-19.

In what could be a breakthrough in the disease management of Covid, the interim results indicate that PegIFN when administered early on, could help patients recover faster and avoid much of the complications seen in the advanced stages of the disease.

PegIFN in Covid-19 has several add-on advantages compared to other antiviral agents. The treatment regimen would be less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single dose regimen. It would also ensure better compliance. PegIFN has very well-established safety with multiple doses in chronic hepatitis B and C patients since many years.

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Patients on Pegylated Interferon Alpha 2b during the trial also showed 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 findings are in line with recently reported importance of early IFN treatment given in combination with steroids in the treatment of Covid-19.

With these positive results, the Company has applied for an approval for additional indication with the DCGI for the use of PegIFN in the treatment of Covid-19.

Pegylated Interferon Alpha 2b therapy has been very well-established with multiple doses being administered in chronic Hepatitis B and C patients since many years. Type I interferons, including Interferon alpha have been found crucial in the protection against SARS-CoV-2 in the recent publications in the leading journal Science.

Aging reduces the body's ability to produce Interferon Alpha in response to viral infections and may be associated with higher mortality in elderly patients. Pegylated Interferon Alpha 2b given early during infection can replace this deficiency and aid a faster recovery process. The Phase III trials were conducted on 250 patients across 20-25 centres in India and the detailed results of this will be published in a peer-reviewed scientific journal.

(With IANS inputs)

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