USFDAAug 11, 2026, 04:03 PM
Belite Bio FDA Accepts NDA for Tinlarebant with Priority Review
AI Summary
Belite Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted and granted Priority Review designation for its New Drug Application (NDA) for tinlarebant, intended for the treatment of Stargardt Disease Type 1 (STGD1). The FDA has set a PDUFA date of February 12, 2027. The filing was supported by positive results from the Phase 3 DRAGON trial, where tinlarebant showed a statistically significant 35.7% reduction in the growth rate of atrophic retinal lesions compared to placebo. If approved, tinlarebant would be the first FDA-approved treatment for STGD1, a rare inherited retinal disease causing progressive vision loss.
Key Highlights
- FDA accepted New Drug Application (NDA) for tinlarebant for Stargardt Disease Type 1 (STGD1).
- FDA granted Priority Review designation for tinlarebant.
- Prescription Drug User Fee Act (PDUFA) date set for February 12, 2027.
- Tinlarebant demonstrated 35.7% reduction in atrophic retinal lesion growth rate in Phase 3 DRAGON trial.
- If approved, tinlarebant would be the first FDA-approved treatment for STGD1.
- STGD1 affects an estimated 53,000 people in the U.S.
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