After running trials with thousands of patients, Zydus Cadila’s drug Pegylated Interferon Alpha 2b, PegiHepTM has now gone before the Drugs Controller General of India (DCGI) for approval.
The company claimed that 91.15 per cent of patients treated with PegIFN were RT PCR negative by day seven as compared to 78.90 per cent on the standard of care (SOC) arm. But this has to administered early days of the illness.
The phase III trial of the medication shown promising results in treating COVID-19, the company stated.
The company claimed that 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.
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 asPegIFN is a single-dose regimen, the company claimed.
This is an approved drug in India originally approved for Hepatitis C. It was launched in the Indian market in 2011. Now, the drug is used to treat COVID-19 patients.
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.”
Other than a phase II trial in Mexico, the company is also working with the USFDA for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in the US.