The Food and Drug Administration (FDA) has expanded the approval of Fasenra (benralizumab; AstraZeneca) to include self-administration with the Fasenra Pen, a prefilled, single-use autoinjector. Previously, Fasenra, an interleukin-5 antagonist, had only been available as a prefilled syringe for administration by a healthcare professional for add-on maintenance treatment of severe eosinophilic asthma.
The approval was based on data from the phase 3 GRECO trial and the phase 1 AMES trial. GRECO was a multicenter, open-label, 28-week trial that evaluated the functionality, reliability and performance of Fasenra single-use auto-injector given in a clinic and in an at-home setting in 120 adults with severe, uncontrolled asthma. Patients received a fixed 30mg dose of Fasenra administered subcutaneously every 4 weeks. Results demonstrated Fasenra autoinjector achieved its primary end points with 97% of at-home administrations considered successful at week 12 and 16 and 96% of returned prefilled autoinjector devices passing visual inspection and function tests.
AMES was a multicenter, randomized, open-label, parallel-group trial that compared the pharmacokinetic (PK) exposure following a fixed 30mg dose of Fasenra administered subcutaneously using either a prefilled syringe or single-use autoinjector in 180 healthy patients. The formulations demonstrated comparable PK exposure with a rapid depletion of eosinophils.
Regarding safety, Fasenra Pen had a similar adverse event profile observed in previous studies. The most common treatment-emergent adverse events from the GRECO trial were viral upper respiratory tract infection, asthma, upper respiratory tract infection, and headache.
Mene Pangalos, Executive VP, BioPharmaceuticals R&D, said: “Fasenra is the only respiratory biologic that can be given every 8 weeks after the initial loading-dose period. Today’s news means we can now offer Fasenra in an even more convenient way, giving US healthcare providers and patients the option of administering Fasenra at home or in a doctor’s office, and making treatment more accessible to patients with severe eosinophilic asthma.”
The new autoinjector device includes a viewing window and audible clicks to guide patients and caregivers through successful administration into the upper arm, thigh or abdomen. The single-dose (30mg/mL) autoinjector is expected to be available soon.
For more information visit astrazeneca-us.com.