Zydus Cadila gets approval from Mexican authority to test COVID-19 drug
Drug firm Zydus Cadila on Monday said it has received approval from Mexico's regulatory authority Cofepris to test one of its lead research candidate Desidustat in the management of COVID-19.
"Clinical and regulatory development of Desidustat in COVID-19 is being executed in Mexico by Avant Sant Research Center S.A. de C.V., a leading contract research organisation headquartered in Monterrey, Mexico," Cadila Healthcare said in a regulatory filing.
The company said it will conduct a study to evaluate the efficacy and safety of Desidustat tablets for the management of COVID-19 patients.
"As a part of the study, 100 mg tablets of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial," the company added.
Zydus Cadila Chairman Pankaj R Patel said, At Zydus, we have been stepping up our efforts to fight the COVID-19 pandemic through therapeutic drugs, diagnostics, and vaccines. With Desidustat we will study a novel approach for management of COVID-19."
Zydus had initiated two phase-III trials of Desidustat.
Last week, Zydus, a part of the Cadila Healthcare group, had received approval from Indian authorities to start human trials for its COVID-19 vaccine contender — the second Indian pharmaceutical firm to get such nod amid a surge in novel coronavirus infections worldwide.
ZyCoV-D, developed at the company's Vaccine Technology Centre in Ahmedabad, has now received permission from the Drug Controller General of India (DCGI) - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India, Cadila Healthcare said in a regulatory filing.
Shares of Cadila Healthcare, the listed entity of the group, were trading at Rs 363.40 a piece on BSE, 0.78 percent lower against their previous close.
(Disclaimer: Additional background information has been added to this PTI copy for context)