Takeda gets European MAA approval for ixazomib
pharmafile | August 21, 2015 | News story | Medical Communications, Research and Development | (FDA/EMA/MHRA), FDA/EMA/MHRA, Takeda, ixazomib, multiple myeloma
Takeda has announced that the European Medicines Agency (EMA) has accepted its Marketing Authorisation Application (MAA) for ixazomib, an investigational oral proteasome inhibitor for the treatment of patients with relapsed and/or refractory multiple myeloma.
On July 23, ixazomib was granted accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP) of the EMA, a designation reserved for those medicines deemed to be of major public health interest and, in particular, therapeutic innovation.
Melody Brown, vice president of regulatory affairs, Takeda, comments: “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.”
The MAA submission was largely based on the results of the first pre-specified interim analysis of the pivotal Phase 3 trial TOURMALINE-MM1, an international, randomised, 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 will be evaluated for long-term outcomes.
Joel Levy
Related Content
Heidelberg Pharma gains FDA ODD for ATAC candidate
Heidelberg Pharma has announced that it has gained Orphan Drug Designation (ODD) from the US …
MHRA approves Takeda’s Hyqvia for chronic inflammatory demyelinating polyneuropathy treatment
Takeda has announced that the Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing …
GSK shares results from phase 3 trial for Blenrep for treatment of multiple myeloma
GSK has announced positive results from an interim analysis of the DREAMM-8 phase 3 head-to-head …
