The US Food and Drug Administration (FDA) has approved self-administration AstraZeneca‘s asthma drug Fasenra, a pre-filled, single-use auto-injector.
The FDA issued its approval based on the Phase III GRECO trial and the Phase I AMES trial data.
The pen injects 30mg of asthma medication Fasenra (benralizumab). The monoclonal antibody (mAb) directly binds to interleukin-5 (IL-5) receptor alpha on eosinophils, triggering apoptosis.
AstraZeneca BioPharmaceuticals R&D executive vice-president Mene Pangalos said: “Fasenra is the only respiratory biologic that can be given every eight 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 GRECO trial assessed the functionality, performance and reliability of the pre-filled auto-injector device.
The trial assessed patient or caregiver‑reported functionality, performance and reliability of the pre-filled auto-injector device, with a 30mg dose of the drug administered subcutaneously (SC) every four weeks in a clinic and an at‑home setting in 120 adults with severe, uncontrolled asthma.
AMES trial compared the exposure of pharmacokinetic (PK) in healthy individuals after a single 30mg SC administration of the drug.
Trial results showed that the safety and tolerability of the drug were consistent with its profile, without any new or unexpected safety findings.
In July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for Fasenra Pen.
It is also indicated as an add-on maintenance treatment for severe, eosinophilic asthma in the EU, US, Japan and other markets.