Virendra Pandit
New Delhi: India’s leading pharmaceutical company Cadila Healthcare Ltd (Zydus Cadila) on Friday received emergency use approval (EUA) from the drug regulator for the use of its anti-viral drug ‘Virafin’ which, it said, can reduce the need for oxygen support and improve recovery time among moderate cases of Covid-19.
The Drug Controller-General of India (DCGI) approved it at a time when India’s healthcare infrastructure is reeling under tremendous pressure due to mounting caseload in the second wave of the pandemic.
The Ahmedabad-based Zydus Cadila said there is an 80.36 percent chance of a patient recovering from coronavirus in seven days, as compared to 68.18 percent in the case of existing modes of treatment.
It said 91.15 percent of adult patients treated with Virafin tested negative for coronavirus using RT-PCR negative in seven days. A Pegylated Interferon alpha-2b drug, Virafin, is to be administered in a single dose subcutaneous (under the skin) regimen, according to media reports.
When administered early, Virafin will help patients recover faster and avoid many complications. It will be available on the prescription of a medical specialist for use in hospital/institutional setups. Evidence shows that Virafin is reducing respiratory distress.
In the multi-centric trial conducted in 20 to 25 centers across India, Virafin showed a lesser need for supplemental oxygen, indicating that it was able to control respiratory distress and failure, one of the major challenges in treating Covid-19.
The drug has also shown efficacy against other viral infections.
Dr. Sharvil Patel, Managing Director, Cadila Healthcare, said, “The fact that we are able to offer a therapy which significantly reduces the 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 with access to critical therapies in this battle against Covid-19.”
In its Phase III clinical trials, researchers found that a higher proportion of patients administered Virafin tested negative for the infection by the seventh day. “The drug ensures faster viral clearance and has several add-on advantages compared to other anti-viral agents,” the company said.
Virafin, when administered in the early phases of Covid-19, can replace the deficiency of Interferon Alpha in the body. A large subgroup of interferon proteins that help regulate the activity of the human immune system, Type I interferons, are the body’s first line of defense against many viral infections.
With aging, the body’s ability to produce Interferon Alpha weakens in response to viral infections. This can be associated with higher mortality observed among elderly Covid-19 patients.
In Phase II clinical trials, Zydus found that there was a significant reduction of the viral load among Covid-19 patients treated with Virafin.
The hours of supplemental oxygen required to treat Covid-19 patients administered Virafin was also significantly less.
Similarly, it was found that the signs and symptoms of patients treated with Virafin remained for five days as compared to six days for patients treated using existing modes of treatment.
Findings of the Phase III trials have been published in the ‘Nature’ journal titled ‘Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107’, while the findings of Phase II clinical trials have been published in the International Journal of Infectious Diseases titled ‘Efficacy and safety of pegylated interferon alfa-2b in moderate COVID-19: A phase II, randomized, controlled, open-label study.