9 September 2015 - Takeda Pharmaceutical Company Limited today announced that the U.S. Food and Drug Administration (FDA) has granted priority review status to the new drug application (NDA) for ixazomib citrate, the first investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.

“We are encouraged that both the U.S. and European regulatory bodies have determined that the ixazomib applications qualify for an expedited review, underscoring the importance of new treatment options for patients with relapsed/refractory multiple myeloma,” said Melody Brown, Vice President of Regulatory Affairs, Takeda. “Our ixazomib program is designed to evaluate whether sustained therapy with an oral proteasome inhibitor improves the outcomes of patients living with multiple myeloma. There is a significant unmet medical need in multiple myeloma and we look forward to working with the regulatory bodies to bring ixazomib to patients.”

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 citrate was recently granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

For more details, go to: http://www.takeda.com/news/2015/20150909_7117.html