Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that the European Medicines Agency (EMA) has accepted the Marketing Authorization Application (MAA) for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. On July 23, ixazomib was granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the EMA, a designation reserved for those medicines deemed to be of major public health interest and, in particular, therapeutic innovation.
“The ixazomib applications in Europe and the United States are the first of several that we anticipate submitting by the end of this fiscal year,” said Melody Brown, Vice President of Regulatory Affairs, Takeda. “By filing in many regions in rapid succession, we hope to bring ixazomib to as many people living with relapsed/refractory multiple myeloma as soon as possible. We express our thanks to the patients and physicians participating in the TOURMALINE clinical trial program globally as their support has been critical in making these filings possible.”
The MAA submission was primarily based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial TOURMALINE-MM1, an international, randomized, double-blind, placebo controlled clinical trial of 722 patients designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/or refractory multiple myeloma. Patients continue to be treated to progression in this trial and will be evaluated for long-term outcomes.
In addition to the ixazomib MAA submission with the EMA, a New Drug Application for ixazomib was filed with the U.S. Food and Drug Administration (FDA). Additional filings in other countries are planned to begin later this fiscal year.