Zydus gets USFDA Orphan Drug Designation for Desidustat for Sickle Cell Disease
ZYDUSLIFE · price
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Zydus Lifesciences announced that the USFDA has granted Orphan Drug Designation (ODD) to its novel drug Desidustat, an oral HIF-PHI molecule, for treating Sickle Cell Disease (SCD), a rare condition affecting fewer than 200,000 people in the US. A Phase II proof-of-concept study has been completed. ODD brings benefits like tax credits, user fee exemptions, and eligibility for seven years of marketing exclusivity upon USFDA approval.
Positive regulatory milestone. ODD boosts Desidustat's commercial potential in the US and could attract partnerships, though final approval is still pending.