BridgeBio Pharma gets FDA priority review for dwarfism drug
Drugmaker BridgeBio Pharma's experimental oral drug infigratinib has been granted priority review by the U.S. Food and Drug Administration (FDA) for treating achondroplasia, the most common form of dwarfism in children. The FDA has set February 4, 2027, as the target decision date. A late-stage study showed children treated with the drug grew 1.74 cm per year faster than those on placebo.
S. FDA granted priority review to its application seeking approval of experimental oral drug infigratinib for children with achondroplasia, the most common form of dwarfism. The FDA set Feb. 4, 2027, as the target date for its decision.
The application is supported by a late-stage study that met its main and key secondary goals. 74 cm per year faster than those given placebo. The drug also improved arm span and body proportions among children younger than eight, and no serious side effects linked to the drug or treatment-related discontinuations were reported. BridgeBio said it plans to seek European approval in Q4 2026.
5% year to date.