EMA Accepts Takeda’s MAA for Myeloma Drug

The European Medicines Agency (EMA) has accepted Takeda Pharmaceutical Company Limited’s marketing authorization application (MAA) for ixazomib, an investigational oral proteasome inhibitor for treating relapsed and/or refractory multiple myeloma. In July 2015, ixazomib was granted accelerated assessment by the EMA’s Committee for Medicinal Products for Human Use , a designation reserved for those medicines deemed to be of major public health interest and, in particular, therapeutic innovation.

In addition to the ixazomib MAA submission with the EMA, a new drug application for ixazomib was filed with the US Food and Drug Administration. Additional filings in other countries are planned to begin later this fiscal year.

Ixazomib is an investigational oral proteasome inhibitor that is 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 is also the first oral proteasome inhibitor to enter Phase II clinical trials.

Source: Takeda Pharmaceutical

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