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April 5, 2021

Zydus Cadila seeks DCGI approval for use of Hepatitis C drug for Covid-19 

Zydus Cadila has sought approval from the Drug Controller General of India (DCGI) for the use of the Hepatitis C drug, Pegylated Interferon Alpha-2b (PegIFN), for treating Covid-19 patients.

Zydus Cadila has sought approval from the Drug Controller General of India (DCGI) for the use of the Hepatitis C drug, Pegylated Interferon Alpha-2b (PegIFN), for treating Covid-19 patients.

Branded as ‘PegiHep’ by Cadila, the drug is approved for Hepatitis C treatment. It was introduced in the Indian market in 2011.

The latest development follows promising interim results from its Phase III clinical trials of PegiHep for treating Covid-19.

The trials were carried out on 250 subjects with Covid-19 across 20-25 centres in the country. In both the arms, subjects were given standard of care, which included steroids in some patients.

As per the results, early administration of PegIFN aided in the faster recovery of Covid-19 patients and avoided many complications observed in the advanced disease stages.

Data showed that 91.15% of patients in the PegIFN arm were RT PCR negative by day seven versus 78.9% on the standard of care (SOC) arm.

In the PegIFN arm, the duration for supplemental oxygen was reduced to 56 hours from 84 hours in moderate Covid-19 patients, signifying the potential in controlling respiratory distress and failure, major challenges in treating Covid-19.

Furthermore, the time to resolution of signs and symptoms was five days in the PegIFN arm as compared with six days in the SOC arm.

Zydus Cadila Healthcare managing director Dr Sharvil Patel 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.”

The company is currently carrying out a Phase II trial in Mexico. It is working with the US Food and Drug Administration for Pegylated Interferon alpha-2b to begin necessary clinical trials in the US.

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