This Orphan Drug Designation from the USFDA underlines the urgent medical need to develop a therapy for sickle cell disease
Orphan drug designation (ODD) by the USFDA for Desidustat, provides eligibility for a potential seven-year marketing exclusivity subject to the USFDA approval
The partnership marks a pivotal step towards developing new therapies for combating Sickle Cell Disease
Desidustat, administered orally is a novel, oral Hypoxia-Inducible Factor-Prolyl Hydroxylase Inhibitor (HIF-PHI) for treating anaemia in Chronic Kidney Disease (CKD) patients
The drug will be marketed by Sun Pharma under the brand name RYTSTAT
The Phase IV DREAM-CKD trial will enrol 1004 CKD patients in India, including 502 dialysis dependent, 502 dialysis independent CKD patients with anemia.
Desidustat is currently approved only in India as OxemiaTM for patients with CKD induced anemia
The DREAM-ND Phase III trial has now enrolled 588 CKD patients not-on-dialysis.
Studies suggest that the protein Sclerostin plays a key role in the dysregulation of bone metabolism
OxemiaTM (Desidustat) is an oral tablet formulation that is the first-in-India alternative to injectable erythropoietin-stimulating agents (ESAs)
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