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Home Industry News Takeda’s new myeloma drug accepted for EU review

Takeda’s new myeloma drug accepted for EU review

21st August 2015

Takeda has announced that its investigational oral proteasome inhibitor ixazomib has been accepted for EU review as a treatment for patients with relapsed and/or refractory multiple myeloma.

The European Medicines Agency (EMA) has accepted Takeda's marketing authorisation application for the drug, which has been granted accelerated assessment by the Committee for Medicinal Products for Human Use of the EMA.

Accelerated assessment status is given to innovative medicines deemed to be of major public health interest.

Data from the first pre-specified interim analysis of the pivotal phase III trial TOURMALINE-MM1 has shown the superiority of ixazomib plus lenalidomide and dexamethasone over a placebo-based treatment.

A new drug application for ixazomib has also been filed with the US Food and Drug Administration, with additional filings in other countries planned to begin later this fiscal year.

Melody Brown, vice-president of regulatory affairs at Takeda, said: "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."ADNFCR-8000103-ID-801798320-ADNFCR

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