Zydus seeks DCGI approval for using PegIFN in COVID-19 treatment

05 April 2021 | News

91.15% of patients treated with PegIFN were RT PCR negative by day 7 as compared to 78.90% on the standard of care (SOC) arm

Image credit- shutterstock.com

Image credit- shutterstock.com

Zydus Cadila has announced that its Phase III clinical trials with Pegylated Interferon Alpha 2b, PegiHep (PegIFN) has shown promising results in treating COVID-19.

In what could be a breakthrough in the disease management of COVID-19, the interim results indicate that PegIFN (Interferon) when administered early on, could help patients recover faster and avoiding much of the complications seen in the advanced stages of the disease.

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.

PegIFN has very well-established safety with multiple doses in chronic hepatitis B and C patients since many years. Patients on Pegylated Interferon Alpha 2b during the trial also showed 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 findings are in line with recently reported importance of early IFN treatment given in combination with steroids in the treatment of COVID-19 (Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107, a Nature publication.

With these positive results, the Company has applied for an approval for additional indication with the DCGI for the use of PegIFN in the treatment of COVID 19.

Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., 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. With Indian Innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapeutics, this marks an important milestone. 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.”

Besides conducting a Phase 2 trial in Mexico, the Company is also working with the USFDA for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US.

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