Shots:
- Belite Bio submitted a New Drug Application (NDA) to Japan’s MHLW for once-daily oral tinlarebant (LBS-008) for the treatment of Stargardt disease type 1 (STGD1)
- The NDA was submitted under Japan’s Sakigake Designation System, following tinlarebant’s designation as a Sakigake pharmaceutical product; if approved, it could become the first approved treatment for STGD1 and the first Sakigake ophthalmology pharmaceutical product in Japan.
- Tinlarebant is designed to reduce serum retinol binding protein 4 (RBP4) and limit vitamin A-derived bisretinoid formation; the Japan NDA was filed alongside the US NDA to support potential early access in both regions.
Ref: GlobeNewswire | Image: Belite Bio | Press Release
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