Shilpa Medicare, together with mAbTree Biologics AG, announced that the U.S. FDA has granted Orphan Drug Designation (ODD) to their breakthrough biologic product. This investigational monoclonal antibody targets rare, chronic blood cancers—Essential Thrombocythemia (ET) and Polycythemia Vera (PV). The designation offers development support and market exclusivity upon approval. This is a key milestone in advancing new treatment options.
FDA Designation for Novel Biologic
Shilpa Biologicals Pvt Ltd, a part of the Shilpa Medicare Group, and mAbTree Biologics AG announced that their flagship biologic product has received Orphan Drug Designation (ODD) from the U.S. Food and Drug Administration (FDA). This monoclonal antibody is under development for treating Essential Thrombocythemia (ET) and Polycythemia Vera (PV), which are rare, chronic blood cancers.
Significance of Orphan Drug Designation
The Orphan Drug Designation recognizes the seriousness of ET and PV. It also acknowledges the potential of this first-in-class, immunology-driven biologic. It aims to modify disease progression instead of merely managing symptoms. The designation provides regulatory and commercial incentives. This includes development support, tax credits, and market exclusivity upon approval.
Advancing Clinical Development
Dr. Sridevi, Chief Executive Officer of Shilpa Biologicals Pvt. Ltd., stated that this milestone validates the collaboration with mAbTree Biologics. Following this regulatory milestone, Shilpa Biologicals and mAbTree Biologics AG will advance the program through IND-enabling studies. Their objective is to initiate first-in-human clinical trials in patients with ET and PV.
Targeting Immune Dysregulation
Raj Andhuvan, Chief Executive Officer of mAbTree Biologics AG, emphasized that the Orphan Drug Designation validates the differentiated mechanism behind the program. By targeting immune dysregulation, which is recognized as a central driver of disease persistence in myeloproliferative neoplasms, this biologic has the potential to establish a new therapeutic paradigm in rare blood cancers.
Source: BSE
