Zydus Cadila seeks DCGI nod for Hepatitis drug use in C-19 patient

The drug, originally approved for use in chronic hepatitis B and C patients

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Zudus
VG Somani DCGI
Dr. VG Somani, DCGI

New Delhi: Zydus Cadila has submitted its application to Dr V.G. Somani the Drugs Controller General of India (DCGI) for the repurposing of hepatitis drug PegiHep in hospitalised C-19 patients after a phase 3 clinical trial, conducted by the company, showed a single dose was significantly better in treating the acute respiratory disease.

In a phase 3 trial of 250 patients across about two dozen centres in India, Zydus Cadila found that 91.2% of patients treated with the drug were RT-PCR negative by the seventh day as compared to 78.9% in patients given standard of care.

The drug, originally approved for use in chronic hepatitis B and C patients also reduced the duration for supplemental oxygen to 56 hours from 84 hours in moderate C-19 patients in the hospital.


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