Zydus' Desidustat gets USFDA Orphan Drug Status for Sickle Cell Disease

• Zydus Lifesciences' Desidustat, an oral product, received Orphan Drug Designation from the USFDA for Sickle Cell Disease.
• Orphan status is granted for rare diseases affecting fewer than 200,000 people in the US, highlighting an urgent medical need.
• Zydus MD Sharvil Patel emphasized Desidustat's potential to address the limited therapeutic options for SCD.
• A Phase II study on Desidustat's efficacy and safety for SCD treatment has been completed, with data pending publication.
• The designation offers development incentives like tax credits, user fee exemptions, and potential seven-year marketing exclusivity.