BBP-418 (ribitol)
Limb-girdle muscular dystrophy type 2I/R9 · Individuals with limb-girdle muscular dystrophy type 2I/R9
BBIO · BridgeBio
Regulatory designations
Full timeline
5 milestonesFDA decision expected
FDA assigned a November 27, 2026 PDUFA target action date to the BBP-418 NDA.
BridgeBio — NDA acceptance and PDUFA date↗FDA accepted the NDA with Priority Review
FDA accepted the traditional-approval application and said it did not then plan an advisory committee meeting.
BridgeBio — NDA acceptance and Priority Review↗Additional FORTIFY results were presented
The Phase 3 interim analysis showed consistent efficacy across prespecified subgroups and improvement across key functional endpoints.
BridgeBio — Detailed FORTIFY interim results↗FORTIFY met all interim-analysis endpoints
The Phase 3 study met its primary and secondary interim endpoints, including measures of alpha-dystroglycan glycosylation, muscle damage, ambulatory function and pulmonary function.
BridgeBio — Positive Phase 3 FORTIFY results↗Related News
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