Caliway Biopharmaceuticals’ CBL-514 Receives the EMA’s Orphan Drug Designation for the Treatment of Dercum’s Disease
Shots:
- The EMA has granted Orphan Drug Designation to CBL-514 (small molecule) for treating Dercum’s disease, providing 10yrs. market exclusivity on approval. It also received the US FDA’s FTD and ODD for the same
- Caliway's completed P-II (CBL-0201DD) trial of CBL-514 showed a dimension reduction of >50% in 64.5% of painful lipomas and complete clearance of 38.7% painful lipomas, with reduced pain by 4.7 points
- A P-IIb (CBL-0202DD) trial to assess the safety & efficacy of CBL-514 vs PBO in Dercum’s disease began recruitment in Aug 2024 across the US, with results expected in Q4’25. A global P-III trial for non-surgical fat reduction is planned for 2025
Ref: Caliway | Image: Caliway
Related News:- Caliway Reports the IND Acceptance of CBL-514 by the US FDA for the Treatment of Dercum's Disease
PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com
Click here to read the full press release
Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.
