Takeda Gets Priority Review for Multiple Myleloma Drug
The US Food and Drug Administration (FDA) has granted priority review status to Takeda Pharmaceutical Company Limited’s new drug application for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.
The FDA may grant priority review status, which includes expedited review, to the evaluation of applications for drugs that treat a serious condition and, if approved, would provide a significant improvement in safety or efficacy over existing treatment. Ixazomib was recently granted accelerated assessment by the Committee for Medicinal Products for Human Use of the European Medicines Agency.
Ixazomib is an investigational oral proteasome inhibitor 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 US and Europe in 2011 and for AL amyloidosis in both the US and Europe in 2012. Ixazomib received breakthrough therapy status by the FDA for relapsed or refractory AL amyloidosis in 2014. It was also the first oral proteasome inhibitor to enter Phase III clinical trials, according to Takeda.