pharmafileMay 25, 2018
Tag: FDA , castration-resistant , Prostate Cancer
Sun Pharma is celebrating with the announcement that its CYP17 inhibitor Yonsa (abiraterone acetate) has been awarded FDA approval in combination with methylprednisolone for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult patients.
Yonsa has been designed using Churchill Pharmaceuticals’ SoluMatrix Fine Particle Technology manufacturing process to offer a micronised formulation of abiraterone acetate tablets, allowing it to be more efficiently absorbed in the body. The active ingredient is converted in vivo to abiraterone, an androgen biosynthesis inhibitor that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17).
As part of an existing deal between the pair, Churchill Pharmaceuticals will receive upfront, commercial milestone payments and royalties related to sales of the drug in the US, where Churchill will handle marketing duties.
"We are pleased to add Yonsa to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies," commented Sun Pharma’s North American CEO Abhay Gandhi.
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