Relief Therapeutics Faces FDA Setback for RLF-TD011 QIDP Designation

Relief Therapeutics Holding SA announced that the U.S. FDA has declined its request for QIDP designation for RLF-TD011, intended for treating epidermolysis bullosa (EB). The FDA concluded that the therapy does not meet the QIDP criteria at this stage. Despite this, Relief's development strategy for RLF-TD011 remains unaffected, as the therapy continues to hold Orphan Drug and Rare Pediatric Disease designations, offering potential benefits like seven years of U.S. market exclusivity upon approval.

Relief engaged in a pre-IND meeting with the FDA, discussing steps to advance RLF-TD011 to later development stages. The company anticipates completing this process soon. RLF-TD011, leveraging Relief's TEHCLO™ technology, is a sprayable hypochlorous acid solution with strong antimicrobial properties, showing promise in infection control and wound healing, especially for severe EB cases.