Yonsa approved by the FDA for metastatic castration-resistant prostate cancer.- Sun Pharma.
Sun Pharmaceutical Industries Ltd and Churchill Pharmaceuticals, LLC. announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the FDA for Yonsa (abiraterone acetate), a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Yonsa in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b) regulatory pathway and will be promoted as a branded product in the US.
Comment: Yonsa is a CYP17 inhibitor which uses proprietary SoluMatrix Fine Particle Technology to create a micronized (smaller particle size) formulation of abiraterone acetate tablets - for the treatment of metastatic castration-resistant prostate cancer, in combination with methylprednisolone. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 ?-hydroxylase/C17,20-lyase (CYP17). The CYP17 enzyme is expressed in testicular, adrenal and prostatic tumor tissues and is required for androgen biosynthesis.
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