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# AstraZeneca Self-administration Fasenra Approved
- URL: https://www.fdaweb.com/astrazeneca-self-administration-fasenra-approved/
- Published: 2019-10-04T12:00:00.000Z
- Updated: 2026-09-15T01:54:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145172

FDA has approved AstraZeneca’s self-administration version of Fasenra (benralizumab) Pen in a pre-filled, single-use auto-injector as an add-on maintenance treatment for severe eosinophilic asthma. The approval is based on data from the Phase 3 GRECO trial and the Phase I AMES trial. “The safety and tolerability of Fasenra in these trials were consistent with the established profile of the medicine,” the company says. “Fasenra is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).”

The self-administration version of the product provides the option of administering Fasenra at home or in a doctor’s office through a two-step process. “The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration,” AstraZeneca says.