Shots:

• The approval was based on P-III trial from the ASCERTAIN study supporting P-I and P-II clinical studies which evaluated the safety and efficacy including decitabine exposure equivalence in oral Inqovi vs intravenous decitabine
• Otsuka a subsidiary of Astex Pharmaceuticals with its partner Taiho Pharmaceutical and North American reported the approval
• Inqovi is a novel product orally administered hypomethylating agent approved by the US and Health Canada for the treatment of MDS and CMML

 ­ Ref: Otsuka | Image: Otsuka