Caliway Biopharmaceuticals Receives EMA Orphan Drug Designation for CBL-514 in Dercum’s Disease Treatment
1 min read
Dercum’s disease patient
WellnessNewsPh | NEW TAIPEI CITY, — Caliway Biopharmaceuticals (Caliway) has announced that the European Medicines Agency (EMA) has granted Orphan Drug Designation (ODD) to CBL-514 for the treatment of Dercum’s disease. This designation provides Caliway with access to significant clinical development support, fee reductions, and market exclusivity upon approval in the EU.
CBL-514 is the first drug globally to receive both Fast Track and Orphan Drug Designations from the U.S. Food and Drug Administration (FDA) for Dercum’s disease. With these recognitions, Caliway expects to expedite the clinical development of CBL-514.
Results from a Phase 2 study for Dercum’s disease showed that CBL-514 could reduce lipoma dimensions by 50% and improve pain by 4.7 points. A Phase 2b study is currently recruiting subjects, with results expected in Q4 2025.
Dercum’s disease is a rare disorder characterized by painful lipomas. CBL-514 offers new hope for patients with this condition and is positioned as a potential first-in-class therapy. For more information about Orphan Drug Designation, visit the EMA official website.
About Caliway Biopharmaceuticals: Caliway is a Taiwan-based biopharmaceutical company focused on innovative drug discovery. For more information, visit https://www.caliway.com.tw/en
Contact: info@caliway.com.tw
Note: This article contains forward-looking statements and is subject to risks and uncertainties beyond the Company’s control. The Company does not undertake to update information on this site if circumstances change.
