Takeda Pharmaceutical has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommending the conditional approval of Ninlaro (ixazomib) capsules in combination with lenalidomide and dexamethasone for treating adults with multiple myeloma who have received at least one prior therapy.

The CHMP’s positive opinion for the conditional approval of Ninlaro will now be reviewed by the European Commission. For a conditional approval, Takeda is required to provide post-approval updates on safety and efficacy analyses and some other already ongoing studies to demonstrate the treatment’s long-term effects.

Ninlaro received approval from the US Food and Drug Administration in November 2015 following priority review. In the US, it is indicated for use in combination with lenalidomide and dexamethasone for treating patients with multiple myeloma who have received at least one prior therapy. Currently licensed for use in the US, Canada, Israel, and Venezuela, Ninlaro is also under review for approval by a number of regulatory authorities around the world.

Ixazomib was granted orphan drug designation in multiple myeloma in both the US and Europe in 2011 and for amyloid light-chain (AL) amyloidosis in both the US and Europe in 2012. Ixazomib received breakthrough therapy status by the FDA for relapsed or refractory systemic AL amyloidosis in 2014.

Source: Takeda Pharmaceutical