Posted by Michael Wonder on 17 Sep 2024
BridgeBio announces infigratinib is the first ever investigational therapeutic option for achondroplasia to be awarded breakthrough therapy designation by the FDA
17 September 2024 - Breakthrough therapy designation was granted based on preliminary clinical evidence from the PROPEL 2 clinical trial, meeting the FDA’s requirement of potentially demonstrating substantial improvement in efficacy over available therapies on clinically significant endpoint(s).
BridgeBio Pharma today announced that the FDA has granted breakthrough therapy designation to oral infigratinib under development for children with achondroplasia.
