Submits the first New Drug Application to DCGI
Zydus Cadila, a global pharmaceutical company, on Tuesday, announced that it has submitted the New Drug Application (NDA) to the Drug Controller General of India. The company has developed a medicine that will help in the treatment of anaemia in patients with Chronic Kidney Disease (CKD).
The pharmaceutical firm named the drug, Desidustat. The drug is an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor. Desidustat accomplished its primary effectiveness endpoint in both of the phase 3 trials that were held between two groups.
The trials were conducted with 588 CKD patients in the DREAM-ND (non-dialysis) group and 392 CKD patients in the DREAM-D (dialysis) group. The findings will be discussed at upcoming scientific conferences and published in peer-reviewed journals.
“We are excited by this important milestone and thankful to all the patients, investigators, regulators and scientists, who led the discovery and development of Desidustat over the last decade. Desidustat has the potential to provide an oral, safer alternative to currently available injectable erythropoietin stimulating agents (ESAs), by additionally reducing hepcidin, reducing inflammation, and better iron mobilization.”Mr. Pankaj R. Patel, Chairman, Cadila Healthcare Ltd.
He further says, “With patient-centricity at the core of all that we do, we have been looking at innovative approaches to improving the quality of life of patients and bridging unmet needs and with Desidustat we have taken yet another step in this direction.” Chronic Kidney Disease (CKD) is a chronic, progressive medical disorder that is a global unmet healthcare need, characterized by the progressive loss of renal function, eventually leading to kidney failure.
According to a survey, Chronic Kidney Disease is expected to affect 114 million people in India, 132 million people in China, 38 million people in the United States, 21 million patients in Japan, and 41 million people in Western Europe.