Autoinjector Version of Udenyca FDA Approved to Reduce Infection Risk After Myelosuppressive Chemo

A single-dose, prefilled autoinjector version of Udenyca (pegfilgrastim-cbqv) has been approved by the Food and Drug Administration (FDA) for patients with cancer undergoing myelosuppressive chemotherapy to potentially decrease the risk for infection.

Udenyca can be administered to patients the day after chemotherapy to reduce the incidence of febrile neutropenia, or when a patient has a fever and a lower number of neutrophils, a type of white blood cell that fights infection, according to a press release from Coherus, the manufacturer of Udenyca. Patients who have too few neutrophils in the blood having a higher risk for infection.

“The introduction of the autoinjector option for Udenyca, with the ability to be administered at home or in the doctor’s office, will provide increased choice and control for patients and physicians, ultimately making treatment more accessible to patients,” said Dr. Lee Schwartzberg, chief of medical oncology and hematology at the Renown Health William N. Pennington Cancer Institute in Reno, Nevada, said in the release. “There are certain types of cancer patients, those who live far away, have an active lifestyle or who are supporting the needs of a busy family, for whom this option eliminates the need to return to the clinic and enables them to choose the time and place for treatment without having to wear an on-body device.”

This autoinjector’s design allows patients to receive this leukocyte growth factor either in the doctor’s office or at home, according to the release. This can be administered through a push-on-skin activation, allowing patients to receive a complete dose of Udenyca.

“The Udenyca autoinjector represents the first innovation in the pegfilgrastim space in eight years,” said Denny Lanfear, chief executive officer of Coherus, in the release.

Udenyca was first approved by the FDA in 2018 as a biosimilar to Neulasta (pegfilgrastim). In particular, a biosimilar is a biological product that is highly similar to a biological product that has already been approved by the FDA that has no significant difference regarding purity, safety and potency.

Udenyca is currently indicated to decrease the risk for infection in patients with non-myeloid malignancies who are treated with myelosuppressive anti-cancer drugs, according to the release. It is also meant to potentially increase survival of patients who have been exposed to myelosuppressive doses of radiation.

The most common side effects related to Udenyca include bone pain and pain in extremities, according to the release.

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