Amgen Receives Positive CHMP Opinion for Neulasta Delivery System

347513

Amgen announced 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 leukemia and myelodysplastic syndromes).

"With more than 30 years of experience in granulocyte-colony stimulating factor (G-CSF) research, Amgen is committed to providing innovative solutions and developing new ways to improve the patient experience that also bring value to healthcare providers and health systems," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "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 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.

Following 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. The Neulasta Onpro Kit has been approved in the U.S. since August 2015.

One of the most common side effects of myelosuppressive chemotherapy is a low white blood cell count. An abnormally low level of neutrophils, an important infection-fighting white blood cell, is called neutropenia. The fewer neutrophils a patient has – and the longer the neutrophil count remains low – the greater the risk of developing a potentially serious infection.

Febrile neutropenia is neutropenia complicated by a fever. Fever is frequently a sign of infection and, in patients receiving myelosuppressive chemotherapy, it can sometimes be the only sign. Febrile neutropenia is a medical emergency and is associated with several potential downstream consequences.

Neulasta was approved for use in Europe in 2002, and is indicated 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 leukemia and myelodysplastic syndromes).

Neulasta was also approved for use in the U.S. in 2002, and is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Neulasta is also indicated to increase survival in patients acutely exposed to myelosuppressive doses of radiation. Neulasta is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation.

  • <<
  • >>

Comments