Shilpa Medicare, mAbTree Biologics Receive FDA Orphan Drug Designation for Rare Blood Cancers Treatment

Shilpa Biologicals Pvt Ltd, a part of the Shilpa Medicare Group, and mAbTree Biologics AG have announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation (ODD) to their flagship breakthrough biologic product. This investigational monoclonal antibody is being developed for the treatment of Essential Thrombocythemia (ET) and Polycythemia Vera (PV)—rare, chronic blood cancers with significant unmet medical need. The Orphan Drug Designation recognizes the seriousness of ET and PV and the potential of this first-in-class, immunology-driven biologic to modify disease progression rather than merely manage symptoms. This designation provides meaningful regulatory and commercial incentives, including development support, tax credits, and market exclusivity upon approval.