Posted by Michael Wonder on 09 Jul 2020
Astex Pharmaceuticals, Taiho Oncology and Otsuka Pharmaceutical announce Health Canada approval of Inqovi (decitabine and cedazuridine) tablets, oral hypomethylating agent therapy for intermediate and high-risk MDS and C
7 July 2020 - Inqovi is the first orally administered hypomethylating agent approved by the FDA and Health Canada.
Astex Pharmaceuticals, Taiho Oncology and Otsuka today announce that the U.S. FDA and Health Canada have approved Inqovi (decitabine and cedazuridine) tablets. The three companies are all part of the Otsuka group of companies.
Approval was based on data from the ASCERTAIN phase 3 study and supporting phase 1 and 2 clinical studies. The ASCERTAIN phase 3 study evaluated the five-day, decitabine exposure equivalence between oral INQOVI and intravenous decitabine. The safety and efficacy of INQOVI was also assessed in the clinical studies.
