Zydus receives approval from USFDA to initiate clinical trials of Desidustat in cancer patients receiving chemotherapy
? Approximately 1.3 million cancer patients are estimated to be undergoing
chemotherapy every year in the US and ~ 30% to 90% of cancer patients
receiving chemotherapy, develop anemia
? Desidustat, is currently undergoing Phase III clinical development for treating
Anemia in CKD patients; and Phase II(b) studies for management of COVID-19
patients
Ahmedabad, India, July 23, 2020
Zydus, a leading discovery based, global pharmaceutical company today announced that it
has received approval from the USFDA, to initiate clinical trials of Desidustat in
Chemotherapy Induced Anemia (CIA).
Cancer Patients undergoing chemotherapy develop anemia. CIA results in fatigue, impaired
quality of life, discontinuation of chemotherapy and also exposes these cancer patients to redblood cell transfusions. Desidustat is expected to increase the red blood cell count and restore
the erythropoietin levels to the normal levels in the cancer patients with CIA. Estimates
suggest approximately 1.3 million cancer patients undergo chemotherapy every year in the
United States and 30% to 90% of cancer patients receiving chemotherapy develop anemia
Speaking on the development, Pankaj R. Patel, Chairman, Zydus Cadila said,
?Chemotherapy-Induced Anemia or CIA is a serious unmet medical need and there is a need
for novel therapies to address this condition. Desidustat has been specifically designed to
improve haemoglobin, reduce hepcidin and thereby treat anemia. We are committed to
develop Desidustat and support cancer patients battling Chemotherapy Induced Anemia.?
Desidustat is a novel, oral, hypoxia inducible factor prolyl hydroxylase inhibitor, currently
undergoing Phase 3 trials for treating anemia in Chronic Kidney Disease Patients. Zydus had
initiated two Phase III trials of Desidustat. The DREAM-ND Phase III trial is being conducted in 588
CKD patients not-on-dialysis [ClinicalTrials.gov Identifier: NCT04012957]. The DREAM-D Phase
III trial is being conducted in 392 CKD patients on Dialysis [ClinicalTrials.gov Identifier:
NCT04215120]. Desidustat had previously met its primary endpoints in the Phase II clinical studies
and showed good safety profile. The Phase I trials were earlier completed in Australia.
Zydus has also initiated a Phase II(b) trial of Desidustat in Mexico for the management of patients
with COVID-19. [ClinicalTrials.gov Identifier: NCT04463602].
About Zydus
Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops,
manufactures and markets a broad range of healthcare therapies, including small molecule
drugs, biologic therapeutics and vaccines. The group employs nearly 25,000 people
worldwide, including 1,400 scientists engaged in R & D, and is dedicated to creating
healthier communities globally. www.zyduscadila.com