Amgen sought Positive CHMP opinion for Neulasta Onpro kit

Amgen asserted that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending a label variation for Neulasta enabling inclusion of Neulasta Onpro Kit. The Neulasta Onpro kit combines the efficacy of Neulasta with an innovative on-body injector OBI delivery system. Neulasta is mentioned in the European Union for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.

David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen said “The Neulasta Onpro Kit is a showpiece of our patient-centric approach and continued investment in advancing the field of G-CSF administration. This improved administration option not only provides patients with the freedom and independence they seek, but the optimally timed delivery gives peace of mind to physicians and caregivers knowing it helps fight the risk of infection.”

One of the common side effects of myelosuppressive chemotherapy (chemotherapy that decreases the activity of the bone marrow) is a low white blood cell count, or neutropenia. Febrile neutropenia (neutropenia with fever) is a life-threatening complication of myelosuppressive chemotherapy that is associated with an increased risk of hospitalization that is costly to treat.

Post the CHMP positive opinion, the centralized European marketing authorization of Neulasta will be updated to include the delivery system of the OBI in its label. Norway, Iceland and Liechtenstein, as members of the European Economic Area (EEA), will take corresponding decisions on the basis of the opinion of the European Commission.