The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has granted an accelerated assessment to Takeda Pharmaceutical Company Limited’s ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma. The EMA awards an accelerated assessment to those medicines deemed to be of major public health interest and, in particular, therapeutic innovation. Takeda expects to submit a marketing authorization application for ixazomib in the European Union in the coming weeks.

Oxazomib is an investigational oral proteasome inhibitor that is being studied in multiple myeloma, systemic light-chain (AL) amyloidosis, and other malignancies. Ixazomib was granted orphan drug designation in multiple myeloma in both the United States and Europe in 2011 and for AL amyloidosis in both the US and Europe in 2012. Ixazomib received breakthrough therapy status by the US Food and Drug Administration (FDA) for relapsed or refractory AL amyloidosis in 2014. Takeda says it is the first oral proteasome inhibitor to enter Phase III clinical trials.

Source: Takeda