BridgeBio Announces FDA Acceptance and Priority Review of NDA for Oral Infigratinib for Children with Achondroplasia
Key Highlights
- ➤FDA accepted BridgeBio’s NDA for oral infigratinib with Priority Review.
- ➤PDUFA target action date set for February 4, 2027.
- ➤PROPEL 3 delivered +2.10 cm/year AHV treatment effect; p<0.0001.
- ➤PROPEL 3 showed significant improvements in proportionality and arm span.
- ➤BridgeBio anticipates a U.S. launch upon approval.
Expert Statements
Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias
“Being granted Priority Review means we are one step closer to potential FDA approval of the first oral treatment option for children with achondroplasia”
Justin To, Chief Executive Officer of BridgeBio Skeletal Dysplasias
“We also understand that for many families, it’s about more than just height or having an oral option. To that end, we are excited by the data we have generated on arm span, sleep apnea, ear infections, and proportionality, and we remain committed to further evaluate and share the impact of oral infigratinib on measures beyond growth. We are grateful to the families and investigators who have partnered with us, and we are moving with urgency alongside the FDA.”
Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America
“For children and families living with achondroplasia, today’s news represents meaningful progress toward potentially expanding the range of available options”
Michael Hughes, Chair of the Biotech Industry Liaison Committee at Little People of America
“Our community holds diverse priorities and perspectives, and what matters is that individuals and families have meaningful choices as they consider their own healthcare goals. This milestone brings us one step closer to potentially having another option for families to consider together with their healthcare providers. We appreciate BridgeBio’s continued engagement with the achondroplasia community and its efforts to incorporate community perspectives throughout the development process.”
- Accepted for Priority Review with a PDUFA target action date of February 4, 2027; being granted Priority Review by the FDA underscores the significant unmet need for an oral targeted therapeutic option for children with achondroplasia
- If approved, oral infigratinib would be the first and only approved oral therapy and a potential best-in-class treatment option for children with achondroplasia
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