Posted by Michael Wonder on 17 Sep 2016
Takeda receives positive CHMP opinion for conditional approval of Ninlaro (ixazomib), the first oral proteasome inhibitor, for use in patients with multiple myeloma
16 September 2016 - If authorised, Ninlaro will provide a new treatment option for European patients with multiple myeloma who have received at least one prior therapy.
Takeda announced today that the EMA CHMP has adopted a positive opinion, recommending the conditional approval of Ninlaro (ixazomib citrate) capsules in combination with lenalidomide and dexamethasone for the treatment of adult patients with multiple myeloma who have received at least one prior therapy.
If the European Commission ratifies the CHMP’s opinion and authorization is granted, Ninlaro will be the first and only oral proteasome inhibitor approved for use across the European Economic Area, which includes the 28 member states of the European Union as well as Norway, Liechtenstein and Iceland.
