Zydus gets approval to test ‘PegiHep’ as Covid-19 therapy in
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17 July: Zydus Cadila announced that it had received approval from the Mexican regulatory authority COFEPRIS to conduct clinical trials with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHep’.

This will be an open-label, randomized, comparator-controlled study of Pegylated IFN alfa-2b to evaluate safety, efficacy and tolerability in patients with COVID-19.

Zydus had earlier approached the DCGI to investigate the role of Pegylated Interferon alpha-2b for COVID 19 and the clinical trials are now underway.

The Company is also working with USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b.

The treatment option emerged after the publication of two recent peer-reviewed research articles.

First study: Published in Journal of General Virology, June 2020 study demonstrated that Pegylated Interferon was able to completely neutralize SARSCoV-2 virus in vitro.

Second study: Published in Frontiers in Immunology, May 2020 analysed 77 moderate COVID-19 subjects in Wuhan and observed that those who received Interferon alpha-2b showed a significant reduction in the duration of virus shedding period and even in levels of the inflammatory cytokine, IL-6.

Source: https://www.livemint.com/news/world/zydus-gets-approval-to-test-covid19-drug-in-mexico-11594958106811.html
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