Zydus Cadila gets COFEPRIS nod to test Desidustat for COVID-19 management
On Monday, Zydus Cadila, a leading global pharmaceutical company, announced that it has received approval from Federal Commission for Protection against Sanitary Risk (COFEPRIS), Mexico to test Desidustat in the management of COVID-19.
The clinical and regulatory development of Desidustat is being executed in Mexico by Avant Santé Research Centre SA de CV, a contract research organisation (CRO).
Patients infected with COVID-19 display signs of Hypoxia, leading to organ failure and death despite the use of antivirals or ventilators. The attack with the novel Coronavirus pneumonia (COVID-19) will reduce haemoglobin that carries oxygen and carbon dioxide. Desidustat mimics the physiologic effect of altitude on oxygen availability, which in turn, improves oxygen delivery to tissues.
The company will be conducting a Phase 2b, multicenter, open-label, randomised, comparator-controlled study to assess the effectiveness and safety of Desidustat tablet for the management of COVID-19 patients.
Desidustat had previously met its primary endpoints in phase 2 clinical studies and showed good safety profile as its phase 1 trials were completed in Australia.
The share of Cadila Healthcare Ltd was trading at Rs 362.7 with a decline of 0.97 per cent at 11.02 am on BSE.