Zydus gets EUA for single-dose 'Virafin' to treat moderate Covid infection

Zydus says 91.15 per cent of patients treated with PegIFN were RT-PCR negative by day 7. The treatment significantly reduces the hours of supplemental oxygen in the patients

Zydus Cadila on Friday announced that it has received restricted emergency use approval from the Indian drug regulator, Drug Controller General of India (DCGI), for the use of ‘Virafin’, Pegylated Interferon alpha-2b (PegIFN) in treating moderate coronavirus infection in adults. 

The approval follows promising results from a late-stage study of the drug, and comes in the middle of a massive wave of COVID-19 cases in India, which has overwhelmed its health system and left many hospitals short of critical oxygen supplies.

"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," the company said in a filing.

Cadila Healthcare's stock rose sharply after getting the emergency use nod. On Friday, the stock ended trading 3.4% higher on NSE. 

Pegylated Interferon alpha-2b was originally approved for liver disease Hepatitis C and launched in India 10 years ago. It is being repurposed to treat Covid-19.

In the multicentric trial conducted in 20-25 centers across India, Zydus said 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." 

Zydus said the drug has also shown efficacy against other viral infections.

Speaking on the development, Sharvil Patel, Managing Director of Cadila Healthcare 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-3 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 company said.