Zydus seeks DCGI approval for the use of Pegylated Interferon alpha-2b in treating COVID-19

Zydus Cadila on Monday, April 5, 2021, announced that it has sought approval from the Drug Controller General of India (DGCI) for the use of Pegylated Interferon Alpha-2b for treating COVID-19 patients.

Cadila Healthcare in a regulatory filing at BSE said, "Zydus Cadila has announced that its phase III clinical trials with Pegylated Interferon Alpha-2b, PegiHep, have shown results in treating COVID-19." It added, "In what could be a breakthrough in the disease management of COVID-19, the interim results indicate that PegIFN when administered early on could help patients recover faster and avoiding much of the complications seen in the advanced stages of the disease."

It said, 91.15 per cent of patients treated with PegIFN were RT PCR negative by day 7 as compared to 78.90 per cent on the standard of care (SOC) arm. The company claims that PegIFN reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate COVID-19 patients. A single dose administered early on shows high clinical improvement in patients.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare, said, "We are encouraged by the results of Phase III study of Pegylated Interferon alpha 2b which has confirmed the potential to reduce virus titres when given earlier in the disease. At Zydus, we stand committed to our endeavour of supporting patients and caregivers with access to treatment options that are affordable and can help in better disease management of COVID 19 at different stages."

Cadila said that the company is also working with the US Food and Drug Administration (USFDA) for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the US.

Cadila Healthcare said, PegIFN in COVID-19 has several add-on advantages compared to other anti-viral 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.

The company said, the findings are in line with the research papers published in internationally reputed publications – Nature and Science.