EMA accelerated assessment for Takeda’s ixazomib for MM patients

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment to Japan’s largest drugmaker Takeda Pharmaceutical’s (TYO: 4502) 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. The company filed for US approval, its first regulatory filing, earlier this month (The Pharma Letter July 15). The drug has been granted Breakthrough Therapy designation in the USA.