Ixazomib (Ninlaro®) has received a positive recommendation from the Committee for Human Medicinal Products (CHMP) within the European Medicines Agency (EMA) for its use in relapsed myeloma patients. The decision follows an initial negative CHMP recommendation that was appealed by the pharmaceutical company, Takeda.
The appeal was supported by Myeloma Patients Europe (MPE), in close collaboration with Myeloma UK, and along with almost 30 MPE member and non-member associations across Europe. The main objective was jointly encouraged the EMA to reconsider its negative recommendation for ixazomib in a letter submitted to CHMP last month.
The positive opinion of the CHMP still needs the formal approval of the European Commission.
Sarper Diler, president of MPE, said: “We are delighted about the EMA’s final decision. Ixazomib provides an effective treatment option for relapsed myeloma patients. Also, it is the first oral proteasome inhibitor, and is therefore an important option for patients who are unable to go to the hospital regularly”.
Medicines regulation and access to treatments are two key areas where MPE focuses its work and resources to improve the life and care of myeloma patients across Europe. Through its membership in the EMA´s Patients’ and Consumers’ Working Party, MPE contributes the perspectives of myeloma patients to regulatory discussions at the European level. In addition, in order to improve patients´ access to myeloma treatments, MPE´s European Atlas of Access to Myeloma Treatment provides myeloma patient organisations the necessary information, evidence, strategies and skills to advocate for access to treatment in their own countries.
“The CHMP’s rectification regarding ixazomib is a good example of how powerful and effective the collaboration among the MPE community is. We can be very proud of this”, said Ananda Plate, Chief Executive Officer at MPE. “The positive opinion of the CHMP is an important first step for patients in Europe to benefit from ixazomib. However, there is still a lot of work to do, to ensure that every patient in Europe that needs ixazomib can actually access it. We hope that MPE’s Atlas will further support MPE members achieving that at a national level”.