BBP-418 for Limb-girdle muscular dystrophy type 2I/R9
The FDA is expected to decide on BBP-418 for Limb-girdle muscular dystrophy type 2I/R9 by November 27, 2026, under a NDA from BridgeBio Pharma.
What is being decided
BridgeBio Pharma has a NDA under FDA review for BBP-418 in Limb-girdle muscular dystrophy type 2I/R9. Oral ribitol therapy under priority review; LGMD2I/R9 has no approved treatment.
What each outcome would mean
An approval starts a second race rather than ending the first one: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. Our guide to the 90 days after a rare disease approval explains the timeline and the moves families can make on day 1.
A complete response letter would mean the FDA declined to approve in the application's current form. CRLs are often about manufacturing or data presentation rather than efficacy, and resubmission is common. Either way, this page updates with the outcome and what it means.
Get notified when new trials open or existing trials change for your condition.
Frequently asked questions
When will the FDA decide on BBP-418?
The FDA's target decision date (PDUFA date) for BBP-418 in Limb-girdle muscular dystrophy type 2I/R9 is November 27, 2026, disclosed by BridgeBio Pharma. The agency can act before this date and occasionally runs past it.
What is BBP-418 being reviewed for?
BridgeBio Pharma submitted a NDA for BBP-418 in Limb-girdle muscular dystrophy type 2I/R9. Oral ribitol therapy under priority review; LGMD2I/R9 has no approved treatment.
What happens after the BBP-418 decision?
If approved, availability is not immediate: specialty pharmacy setup, insurance review, and patient assistance typically take weeks even when everything goes right. If the FDA issues a complete response letter, the application was not approved in its current form; CRLs are often about manufacturing or data presentation rather than efficacy, and sponsors frequently resubmit. This page updates with the outcome either way.
Where this date comes from
The FDA does not publish PDUFA dates; companies disclose them. This one comes from BridgeBio announcement. Dates can move, and the FDA can act early or late. This page rechecks against our calendar, which is re-verified weekly.