Caliway Biopharma's CBL-514 Granted FDA Fast Track for Decrumbs Disease

Caliway Biopharmaceuticals (Caliway) announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to study CBL-514 for treating Dercombe's disease. CBL-514 is a lipolytic injection that can reduce local subcutaneous fat by selectively removing fat cells. It is the first drug in Korea to receive rapid approval for treating Derkum's disease. "We are very pleased that the FDA has decided to grant Fast Track designation to CBL-514," said Vivian Ling, CEO of Carway.

Dercum's disease is a rare disease characterized by the growth of painful lipomas and often causes prolonged pain and confusion. "The Fast Track designation allows Caliway to benefit from collaboration with the FDA to support the collection of clinical data needed to accelerate the development of CBL-514 and bring the drug to market" for patients with this disease.

Fast track designation to accelerate the development and rapid evaluation of drugs to treat serious diseases, address unmet medical needs, and provide treatments that remain unavailable or improve. This is an FDA process—more of the possible treatments.

The FDA's decision was based on the results of Caliway's Phase 2 clinical studies of CBL-0201DD (NCT05387733), which indicated that CBL-514 was the first and only product to show clinical and statistical significance in painful lipomas. Showing More than 50%, the pain improved significantly by 4.7 degrees. Therefore, the Phase 2 CBL-0201DD study demonstrated a significant improvement over available treatments to address the unmet medical need for Dercombe disease. The FDA recognizes the expanded Access Program as a substitute for Fast Track designation. EAPs offer a potential way for patients with serious or life-threatening conditions to access investigational drugs for treatment outside of clinical trials, particularly when there is no equivalent or satisfactory alternative treatment.