Ahmedabad: Zydus Cadila on Friday announced it has received restricted Emergency Use Approval from the Drug Controller General of India (DCGI) for the use of antiviral ‘Virafin’ in treating moderate Covid-19 infection in adults.
The single dose subcutaneous regimen of the anti-viral drug reduced the need for supplemental oxygen, indicating that it was able to control respiratory distress and failure — one of the major challenges in treating Covid-19, according to results of a multicentric trial conducted in 20-25 centres across India.
About 91.15 per cent of patients treated with the drug were RT-PCR negative by day seven, the company said in a statement.
The drug has also shown efficacy against other viral infections, it added. It will be available on the prescription of a medical specialist for use in hospital/institutional setup.
“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 Ltd, said in a statement.
In its Phase 3 clinical trials, the therapy showed better clinical improvement in the patients suffering from Covid-19.
Earlier the Phase 2 clinical trials study established the early safety, efficacy and tolerability of Virafin and indicated that Pegylated Interferon alpha-2b had significant statistical clinical impact on the patient suffering from moderate Covid 19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support.