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Relief Therapeutics Receives FDA Rare Pediatric Disease Designation for RLF-TD011
- Relief Therapeutics gets FDA Rare Pediatric Disease status.
- RLF-TD011 targets epidermolysis bullosa treatment.
- Promising results in wound care and infection control.
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Relief Therapeutics Holding SA / Key word(s): Research Update Relief Therapeutics Receives FDA Rare Pediatric Disease Designation for RLF-TD011 |
GENEVA (May 22, 2025) – RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief or the Company), a biopharmaceutical company committed to delivering innovative treatment options for select specialty, unmet and rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease (RPD) designation to RLF-TD011 for the treatment of epidermolysis bullosa (EB), a rare genetic skin disorder characterized by fragile skin and chronic wounds. The FDA had previously granted Orphan Drug Designation to RLF-TD011 for the same indication.
RLF-TD011 is a differentiated, hypotonic acid-oxidizing solution formulated with hypochlorous acid, designed to deliver potent antimicrobial and anti-inflammatory activity while creating a wound microenvironment conducive to healing. The Company previously reported promising clinical findings supporting RLF-TD011’s potential to meaningfully advance EB wound care by modulating the wound microbiome and reducing pathogenic colonization without disrupting beneficial bacteria.
“The FDA’s decision to grant Rare Pediatric Disease designation to RLF-TD011 underscores both the critical need for new options for patients living with EB and the potential of our investigational therapy,” said Giorgio Reiner, chief scientific officer of Relief. “We look forward to continued engagement with the FDA and to sharing the next steps in our development plan following our upcoming pre-IND meeting.”
The FDA grants RPD designation to product candidates targeting serious or life-threatening diseases that primarily affect individuals aged 18 years or younger and impact fewer than 200,000 people in the U.S. Companies that receive marketing approval for an RPD-designated indication may be eligible—subject to certain conditions, including congressional reauthorization of the program for designations granted after December 20, 2024—to receive a Priority Review Voucher (PRV), which grants expedited FDA review for a future marketing application. These vouchers are transferable; in May 2025, a PRV awarded following the approval of a treatment for a rare form of EB was sold for $155 million.
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