FDA Grants Fast Track Status to SAP-001 for Treatment-Resistant Gout
The FDA has granted Fast Track designation to SAP-001, a new therapy aimed at treating hyperuricemia in adults with gout who do not respond to conventional treatments.
"We are excited about the Fast Track designation for SAP-001" says Dr. Wenfeng Miao, Shanton's CMO. "Refractory gout is a serious condition for which there are considerable unmet medical needs, requiring the development of new treatments. We are pleased to tap into the opportunity for faster regulatory reviews provided by this designation to speed up the availability of a much-needed solution for gout patients who do not respond to or cannot tolerate Standard-of-Care treatment with conventional Urate Lowering Therapies."
FDA's decision to grant the Fast Track designation for SAP-001 was based in part on Shanton's recent efficacy and safety outcomes in a Phase 2b clinical study in which SAP-001 demonstrated the potential to meaningfully improve on currently available Urate Lowering Therapy for refractory gout patients.
About Fast Track
Fast Track is an FDA expedited review program which includes more frequent meetings with FDA, early and ongoing feedback from FDA, rolling review of NDA sections as they become available, and the possibility of priority review and accelerated approval. The purpose is to get important new drugs to patients earlier.
About SAP-001
SAP-001 is Shanton's lead investigational compound for once-a-day oral urate-lowering therapy that targets refractory gout. SAP-001's urate lowering properties are based on a unique, First-in-Class mechanism-of-action and the product has shown Best-in-Class efficacy and safety in gout patients with hyperuricemia refractory to Standard of Care Xanthine Oxidase Inhibitor therapy in a recent Phase 2b study.
