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news.The European Medicines Agency (EMA) has accepted Takeda Pharmaceutical's marketing authorization application (MAA) for ixazomib, an investigational oral proteasome inhibitor, to treat patients with relapsed and/or refractory multiple myeloma.
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In July, ixazomib was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use (CHMP).
The MAA was based on the results of the first pre-specified interim analysis of the pivotal Phase III trial TOURMALINE-MM1, an international, randomized, double-blind, placebo controlled clinical trial of 722 patients.
TOURMALINE-MM1 was 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.
Takeda Regulatory Affairs vice-president Melody Brown said: "The ixazomib applications in Europe and the United States are the first of several that we anticipate submitting by the end of this fiscal year.
"By filing in many regions in rapid succession, we hope to bring ixazomib to as many people living with relapsed/refractory multiple myeloma as soon as possible.
"We express our thanks to the patients and physicians participating in the TOURMALINE clinical trial program globally as their support has been critical in making these filings possible."
Apart from ixazomib MAA submission with the EMA, a new drug application (NDA) for ixazomib was filed with the US Food and Drug Administration (FDA).
The company said that additional filings in other countries are planned to be initiated later this fiscal year. Currently, ixazomib is being studied in multiple myeloma, systemic light-chain (AL) amyloidosis, and other malignancies.