CHMP recommends a label variation to Neulasta to include the Neulasta Onpro Kit.- Amgen.

Amgen has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending a label variation for Neulasta (pegfilgrastim) to include the Neulasta Onpro Kit. The Neulasta Onpro Kit combines the efficacy of Neulasta with an innovative on-body injector (OBI) delivery system.

Neulasta is indicated in the European Union (EU) for the reduction in the duration of neutropenia and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy (with the exception of chronic myeloid leukaemia and myelodysplastic syndromes). One of the most 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. The Neulasta Onpro Kit includes a specifically designed Neulasta pre-filled syringe along with a single use OBI.

The small, lightweight OBI is applied to a patient's skin on the same day of chemotherapy. The OBI is intended to facilitate timed delivery of the correct dose of Neulasta and to improve the quality of life of patients as it removes the burden to return to a healthcare setting the day following chemotherapy, providing advantages over the standard manual injection pre-filled syringe.