Zydus Cadila gets Mexican nod for clinical trials of Pegylated Interferon alpha-2b
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.;
Ahmedabad: Zydus Cadila has announced that it had received approval from the Mexican regulatory authority COFEPRIS to conduct clinical trials with its biological therapy, Pegylated Interferon alpha-2b, 'PegiHepTM' This will be an open-label, randomized, comparator-controlled study of Pegylated IFN alfa-2b to evaluate the safety, efficacy, and tolerability in patients with COVID-19.
Clinical and regulatory development of Pegylated Interferon alpha-2b in COVID-19 is being executed in Mexico by Avant Santé Research Center S.A. de C.V., a leading Contract Research Organization (CRO) headquartered in Monterrey, Mexico.
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.
Speaking on the development, Dr Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, "Our endeavor is to continue looking for pathways for a safe and efficacious treatment to combat COVID 19. Pegylated Interferon-alpha has the potential to reduce virus titers when given earlier in the disease. The focus is on reducing the viral load and generating virus eliminating specific immune response."
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