Takeda Announces European Medicines Agency Acceptance of Ixazomib's Marketing Authorization Application for Patients with Relapsed/Refractory Multiple Myeloma

Takeda Pharmaceutical Company Limited

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,