Zydus receives USFDA Orphan Drug Designation for Desidustat in Sickle Cell Disease Treatment

Zydus Lifesciences Ltd. has received Orphan Drug Designation (ODD) from the USFDA for Desidustat, a novel oral HIF-PHI, for the treatment of Sickle Cell Disease (SCD). The ODD provides eligibility for a potential seven-year marketing exclusivity, subject to the USFDA approval. The Phase II study on Desidustat for SCD has been completed. Desidustat is a HIF-prolyl hydroxylase inhibitor with the potential to increase haemoglobin and red blood cell counts. SCD has limited therapeutic options, with hydroxyurea and blood transfusions being the most common. Orphan drug designation by the USFDA for Desidustat provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions.