Caliway Biopharmaceuticals, a Taiwan-based clinical-stage biopharmaceutical company, announced on Tuesday that it has received Orphan Drug Designation (ODD) from the European Medicines Agency (EMA) for its novel small molecule drug, CBL-514, for the treatment of Dercum's disease, a rare disorder characterised by the development of painful lipomas primarily located on the trunk region, and the extremities close to the trunk.

This designation allows the company to access significant clinical development support, pre-authorisation and post-authorisation activities fee reductions, and a 10-year market exclusivity following approval within the European Union.

The product is the first drug globally to receive dual designations from the US Food and Drug Administration (FDA) -- both Fast Track and Orphan Drug Designations -- for Dercum's disease.

Caliway completed a CBL-514 Phase 2 study (CBL-0201DD, NCT05387733) for Dercum's disease in 2023. Results demonstrated that after administrating CBL-514 treatment, 64.5% of painful lipomas showed a dimension reduction of over 50%, and 38.7% of painful lipomas showed complete clearance, with pain being reduced by 4.7 points.