Amgen’s new Neulasta delivery system recommended for EU approval

Amgen has announced that its Neulasta Onpro Kit has been recommended for approval by the European Medicines Agency.

The agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending a label variation for Neulasta to include this new delivery system, which utilises an innovative on-body injector approach.

Neulasta is indicated in the EU for the reduction in the duration of neutropenia – a condition characterised by a low white blood cell count – and the incidence of febrile neutropenia in adult patients treated with cytotoxic chemotherapy for malignancy.

The Neulasta Onpro Kit is small and lightweight and can be applied to a patient's skin on the same day of chemotherapy, facilitating timed delivery of the correct dose of Neulasta and eliminating the need for the patient to return to hospital the day after chemotherapy.

Dr David Reese, senior vice-president of translational sciences and oncology at Amgen, said: "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."

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