BridgeBio Says FDA Grants Breakthrough Therapy Designation To Oral Infigratinib For Achondroplasia

(RTTNews) - Biopharmaceutical company BridgeBio Pharma, Inc. (BBIO) announced Tuesday that the US FDA has granted Breakthrough Therapy Designation to oral infigratinib under development for children with achondroplasia.

The Breakthrough Therapy Designation is designed to expedite the development and regulatory review of drugs in the U.S. that meet stringent criteria.

Drugs qualifying for this designation must show preliminary clinical evidence that the drug may demonstrate a substantial improvement on clinically significant endpoints over available therapies.

The designation was granted based on PROPEL 2 data, which showed that in Cohort 5, infigratinib resulted in a statistically significant and sustained increase in annualized height velocity (AHV).

PROPEL 3, the global Phase 3 registrational study of infigratinib in achondroplasia, continues to enroll on schedule, with completion of enrollment anticipated by the end of the year.

In addition to receipt of Breakthrough Therapy Designation, infigratinib has also received Orphan Drug Designation, Fast Track Designation, and Rare Pediatric Disease Designation for achondroplasia from the FDA. If infigratinib is approved, BridgeBio may qualify for a Priority Review Voucher.