XRTX - XORTX Therapeutics' Xorlo eligible for accelerated approval confirms FDA
2023-05-04 10:04:37 ET
- 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.
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- The meeting provided clarity on accelerated approval endpoints for XORLO in ADPKD, leading to NDA and marketing approval.
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- Phase 3 trial parameters such as treatment duration, follow-up periods, and preferred statistical analysis were discussed.
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- XORTX will choose its primary endpoint and development strategy based on ongoing discussions with partners.
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- XORTX plans to pursue a Special Protocol Assessment ( SPA ) with the FDA to further de-risk the development of XORLO™ for ADPKD.
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XORTX Therapeutics' Xorlo eligible for accelerated approval, confirms FDA