NE BUSINESS BUREAU
NEW DELHI, JULY 17
Drug firm Zydus Cadila on Friday said it has received approval from Mexico’s regulatory authority Cofepris to conduct clinical trials in the Latin American country with its biological therapy “Pegylated Interferon alpha-2b” for treatment of COVID-19.
Clinical and regulatory development of the therapy in COVID-19 is being executed in Mexico by Avant Santé Research Center S.A. de C.V., a contract research organisation (CRO) headquartered in Monterrey, Mexico.
In a regulatory filing, Zydus Cadila said it had received approval from the Mexican regulatory authority Cofepris to conduct clinical trials with its biological therapy, Pegylated Interferon alpha-2b, ”PegiHepTM”.
It added that “this will be an open-label, randomised, comparator-controlled study… to evaluate safety, efficacy, and tolerability in patients with COVID-19”.
Zydus had earlier approached the Drug Controller General of India to investigate the role of Pegylated Interferon alpha-2b for COVID-19 and the clinical trials are now underway, the company said.
It is also working with the US Food and Drug Administration to open an investigational new drug application for Pegylated Interferon alpha-2b.
Earlier this month, Zydus Cadila had also received approval from Cofepris to test one of its lead research candidate Desidustat in the management of COVID-19.
