The European Medicines Agency's CHMP has reversed its initial negative opinion on Takeda Pharmaceutical Co. Ltd.'s Ninlaro (ixazomib) and has now green-lighted a conditional approval. The news will come as a relief for Takeda, which will now be better poised to offset a decline in sales from Velcade (bortezomib) following impending patent expiry. However, Takeda cannot afford to relax: it will have to work hard to establish Ninlaro in an increasingly crowded market while approval of a promising rival from Janssen looms.
On Sept. 15 the CHMP recommended conditional approval of Ninlaro in combination with lenalidomide (Celgene Corp.'s Revlimid) and dexamethasone...







