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Accelerated Assessment for Ixazomib

July 28, 2015

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European Medicines Agency Grants Accelerated Assessment of Ixazomib for Patients with Relapsed/Refractory Multiple Myeloma.

Takeda Pharmaceutical Company Limited has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted an accelerated assessment to 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 (EU) in the coming weeks. The submission is based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial TOURMALINE-MM1. This study is an international, randomized, double-blind, placebo controlled clinical trial of 722 patients designed to evaluate the superiority of ixazomib plus lenalidomide and dexamethasone over placebo plus lenalidomide and dexamethasone in adult patients with relapsed and/ or refractory multiple myeloma. Patients continue to be treated to progression in this trial and evaluated for long-term outcomes.

“We are pleased that the CHMP has granted accelerated assessment for ixazomib, and believe that this designation underscores the urgent need for therapeutic innovation in multiple myeloma treatments,” said Andrew Plump, M.D., Ph.D., Takeda’s Chief Medical and Scientific Officer. “We look forward to sharing the TOURMALINE-MM1 study data from the first pre-specified interim analysis at an upcoming medical meeting, and greatly appreciate the ongoing dedication and commitment from the patients and their families who have been participating in the ixazomib clinical development program.”

“Continuous therapy is emerging as a standard of care in multiple myeloma because it has demonstrated improved long-term outcomes,” said Philippe Moreau, MD, University Hospital of Nantes in France. “If ixazomib is approved, for the first time physicians will have the option of an all-oral proteasome inhibitor-based regimen for the treatment of multiple myeloma, which could be a real advantage in delivering sustained therapy.”

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