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Belite Bio submits NDA to Japan's MHLW for tinlarebant to treat Stargardt disease type 1 under Sakigake pathway
BLTEBelite Bio, Inc
Belite Bio announced the submission of a New Drug Application (NDA) to Japan's Ministry of Health, Labour, and Welfare for tinlarebant to treat Stargardt disease type 1 under the Sakigake Designation System. This filing coincides with the U.S. FDA acceptance of an NDA for the same indication, which carries a Prescription Drug User Fee Act target action date of February 12, 2027. If approved, tinlarebant would be the first treatment for Stargardt disease type 1 in Japan and potentially the first ophthalmology product to receive approval under the Sakigake pathway. The company's lead candidate has previously met primary endpoints in Phase 3 trials for this condition. Belite Bio is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for degenerative retinal diseases.