DCGI approves Zydus Cadila's Virafin for hepatitis drug for Covid-19 treatment
By Team Newsable | First Published Apr 24, 2021, 4:40 PM ISTEarlier in the month, the company had sought approval from the DCGI for the additional indication of hepatitis drug Pegylated Interferon Alpha-2b for treating Covid-19.
Zydus Cadila on Friday announced that the Drug Controller General of India (DCGI) has given “Restricted Emergency Use Approval” for the use of Virafin, Pegylated Interferon alpha-2b (PegIFN), to treat moderate Covid-19 infection in adults.
Earlier in the month, the company had sought approval from the DCGI for the additional indication of hepatitis drug Pegylated Interferon Alpha-2b for treating Covid-19.
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A single dose subcutaneous regimen of the antiviral drug will make treatment of Covid-19 disease more convenient.
Originally approved for Hepatitis C, the “multicentric trial” of the drug —conducted in 20-25 centers across India — has shown lesser need for supplemental oxygen.
In its regulatory filing, the company said, "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," the company also said.
"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 antiviral agents," it also said.
Dr Sharvil Patel, Managing Director, Cadila Healthcare Limited stated, “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.”
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