BridgeBio Pharma announced that the FDA has granted Breakthrough Therapy Designation, BTD, to oral infigratinib under development for children with achondroplasia. “The receipt of Breakthrough Therapy Designation, the first ever for a treatment being developed for children with achondroplasia, marks another important milestone for our skeletal dysplasia program. This recognition by the FDA further confirms the strength of our Phase 2 data, and the substantial improvement on clinically significant endpoints over available therapies. We are excited by what this means for the community, and we look forward to working closely with FDA to expedite the development of infigratinib and access for families to an oral option,” said Adora Ndu, Pharm.D., J.D., Chief Regulatory Affairs Officer of BridgeBio.
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