XORTX Therapeutics' Xorlo eligible for accelerated approval, confirms FDA
- XORTX Therapeutics (NASDAQ:XRTX) announced a positive outcome of their recent Type D meeting with the U.S. Food and Drug Administration regarding the accelerated approval of XORLO as a treatment for autosomal dominant polycystic kidney disease ((ADPKD). The meeting identified additional clinical endpoints for potential accelerated approval and clarified the FDA's expectations.
- The Type D meeting with the FDA was held to discuss the details of the accelerated approval process, the clinical trial protocol for the XRX-OXY-301 study, and future clinical development plans for XORLO.
- The meeting provided clarity on accelerated approval endpoints for XORLO in ADPKD, leading to NDA and marketing approval.
- Phase 3 trial parameters such as treatment duration, follow-up periods, and preferred statistical analysis were discussed.
- XORTX will choose its primary endpoint and development strategy based on ongoing discussions with partners.
- XORTX plans to pursue a Special Protocol Assessment (SPA) with the FDA to further de-risk the development of XORLO™ for ADPKD.
- Press Release