Shilpa Medicare Ltd

🚀 Shilpa Medicare's Subsidiary Gains FDA Orphan Drug Designation for Rare Blood Cancer Treatment

- Shilpa Medicare's subsidiary Shilpa Biologicals and partner mAbTree Biologics received FDA Orphan Drug Designation for a monoclonal antibody targeting rare blood cancers Essential Thrombocythemia (ET) and Polycythemia Vera (PV).

- The biologic is a first-in-class treatment aiming to modify disease progression, not just manage symptoms, by targeting an immune-evasion pathway in myeloproliferative neoplasms.

- Current treatments for ET and PV include aspirin, interferon-alpha, hydroxyurea, and JAK inhibitors, but many patients become refractory or intolerant over time.

- The companies plan to advance the program through IND-enabling studies, with goals to start first-in-human clinical trials for ET and PV patients.