FDA grants Breakthrough Therapy Designation for oral infigratinib in treating achondroplasia.
BridgeBio Pharma announced that the FDA has granted Breakthrough Therapy Designation for oral infigratinib, aimed at treating children with achondroplasia, a form of dwarfism. This designation accelerates the drug's development due to promising results from the PROPEL 2 study. Infigratinib also holds Orphan Drug, Fast Track, and Rare Pediatric Disease Designations. The Phase 3 study, PROPEL 3, is ongoing and expected to finish enrollment by year-end.
September 17, 2024
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