• Fast Track designation indicates CBL-514’s potential in filling the unmet medical need of Dercum’s disease.
• CBL-514 is the first drug to receive Fast Track designation for Dercum’s disease treatment.
• CBL-514 Phase 2 study in Dercum’s disease demonstrated its efficacy in significant painful lipomas’ size reduction of more than 50%, complete clearance and pain improvement by 4.7 points.
  

New Taipei City, February 15, 2024 - Caliway Biopharmaceuticals (Caliway) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the investigation of CBL-514 in Dercum’s disease treatment. CBL-514 is a lipolysis injection that can reduce local subcutaneous fat by selectively inducing adipocyte apoptosis, and is the first drug to receive Fast Track designation for Dercum’s disease treatment.

“We are very pleased to see the FDA’s decision on granting Fast Track designation to CBL-514,” said Vivian Ling, CEO of Caliway. "Dercum’s disease is a rare disease characterized by the growth of painful lipomas, the pain can often be chronic and disturbing. With the Fast Track designation, Caliway can benefit from more frequent engagement with the FDA, which will support the collection of appropriate clinical data to accelerate CBL-514 development, and provide the treatment to patients who have been suffering with this disease.”

For full release please visit www.caliway.com.tw