AstraZeneca's Fasenra Receives FDA Approval for At-Home Self-Administration via Pre-Filled Auto-Injector

AstraZeneca recently announced that the U.S. FDA has approved a self-administration option for Fasenra (benralizumab), enabling patients to self-administer the medication using a new pre-filled, single-use autoinjector (the Fasenra pen). Notably, Fasenra is now the only respiratory biologic offering a maintenance dosing regimen every 8 weeks, which can be administered either at home or in a physician’s office.

Fasenra self-administration options and the Fasenra Pen have also been approved in the European Union. Currently, Fasenra is approved in the United States, the European Union, Japan, and other countries as an add-on maintenance therapy for the treatment of patients with severe eosinophilic asthma.

For self-administration, Fasenra is administered as a fixed 30 mg subcutaneous injection via a pre-filled syringe or the Fasenra Pen (both using a 29-gauge thin needle), with the first three doses given every 4 weeks, followed by dosing every 8 weeks thereafter. The Fasenra Pen enables patients and caregivers to manage administration through a simple two-step process; the device features a viewing window and audible clicks at the start and end of the injection to guide patients in successful drug administration.

This approval is based on the support of the Phase III clinical study GRECO and a Phase I clinical study AMES. The safety observed in these two studies was consistent with that in other studies, with no new or unexpected safety findings:

— The GRECO study was an open-label, 28-week study that enrolled 120 patients with severe uncontrolled asthma to evaluate subcutaneous administration of Fasenra at a dose of 30 mg every 4 weeks using a pre-filled autoinjector (Fasenra pen) in both clinic and home settings. Data showed that at Weeks 12 and 16, the vast majority (97%) of patients or caregivers successfully administered the medication at home using the pre-filled autoinjector. At Weeks 12 and 16, the vast majority (97%) of pre-filled autoinjectors returned after home use were assessed as functioning properly.

——The AMES study was an open-label Phase I study in healthy subjects that evaluated the pharmacokinetics (PK), or exposure, of a single 30 mg dose of Fasenra administered via prefilled syringe or prefilled autoinjector. The results demonstrated comparable PK exposure of subcutaneously administered Fasenra between the two delivery methods, with rapid reductions in eosinophil counts observed in both groups.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, stated: “Fasenra is the only respiratory biologic administered every 8 weeks following the initial loading dose period. Today’s approval means we can now deliver Fasenra in a more convenient manner, enabling healthcare providers and patients in the United States to choose between administering Fasenra at home or in the physician’s office, thereby improving access to treatment for patients with severe eosinophilic asthma.”

Fasenra Pen (Fasenra Autoinjector)

The active pharmaceutical ingredient of Fasenra is benralizumab, a monoclonal antibody that directly binds to the alpha subunit of the interleukin-5 receptor (IL-5Rα) on eosinophils and uniquely recruits natural killer (NK) cells, inducing rapid and nearly complete depletion of eosinophils through apoptosis (programmed cell death).

Fasenra was licensed to AstraZeneca from BioWa, a wholly owned subsidiary of the Japanese pharmaceutical company Kyowa Hakko Kirin. In late March this year, AstraZeneca and Kyowa Hakko Kirin signed a new agreement, granting AstraZeneca the Asian rights to all indications for Fasenra. In addition to the approved indication for eosinophilic asthma, AstraZeneca is also evaluating the potential of Fasenra in treating severe nasal polyps, eosinophilic esophagitis (EoE), hypereosinophilic syndrome (HES), eosinophilic granulomatosis with polyangiitis (EGPA), and chronic obstructive pulmonary disease (COPD). Previously, the FDA had granted orphan drug designation to Fasenra for the treatment of EoE, HES, and EGPA.

Original Source: Fasenra Approved in the US for Self-Administration in a New Pre-filled Auto-injector, the Fasenra Pen

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