FDA Accepts BridgeBio NDA for Priority Review in Achondroplasia

BridgeBio announced that the U.S. Food and Drug Administration has accepted its new drug application for oral infigratinib for children with achondroplasia and granted the application Priority Review, according to Yahoo News.

The company said the FDA has set a Prescription Drug User Fee Act target action date of February 4, 2027.

Regulatory milestone for oral infigratinib

According to the Yahoo News report, BridgeBio characterized the Priority Review decision as reflecting the significant unmet need for an oral targeted therapeutic option for children with achondroplasia.

If approved, BridgeBio said oral infigratinib would be the first and only approved oral therapy for children with achondroplasia and could represent a potential best-in-class treatment option.

Clinical program cited in the announcement

BridgeBio also cited results from its PROPEL 3 program. The company said PROPEL 3 met its primary endpoint and key secondary endpoints, with the announcement describing the results as delivering the strongest efficacy performance referenced in the report.

For pharmaceutical and biotech sales professionals, the FDA acceptance and Priority Review designation mark a defined regulatory event in BridgeBio’s achondroplasia program. The next stated FDA milestone is the February 4, 2027 target action date.

What the designation means in this program

Priority Review is the FDA review status reported by BridgeBio for this NDA. The designation places attention on the company’s oral targeted-therapy positioning in a pediatric achondroplasia setting, while the application remains under FDA review.

Yahoo News reported the announcement from BridgeBio, including the company’s statements on the unmet need, potential oral-therapy status, clinical program results, and PDUFA target action date.