BridgeBio Gets FDA Breakthrough Therapy Designation for Achondroplasia Treatment

By Don Nico Forbes

BridgeBio said it received breakthrough therapy designation from the U.S. Food and Drug Administration for infigratinib, a treatment under development for children with achondroplasia.

The biopharmaceutical company said Tuesday that the move follows data from Phase 2 trials, in which infigratinib demonstrated improvement in clinical targets compared with other available therapies.

Achondroplasia is a genetic disorder whose primary feature is dwarfism.

BridgeBio said it now plans to expedite the development and regulatory review of infigratinib in the U.S.

"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," said Chief Regulatory Affairs Officer Adora Ndu.

Completion of enrollment for Phase 3 trials is anticipated by the end of 2024, the company said.

Write to Don Nico Forbes at don.forbes@wsj.com

(END) Dow Jones Newswires

September 17, 2024 08:06 ET (12:06 GMT)

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