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# 2 New Nucala Administration Options Approved
- URL: https://www.fdaweb.com/2-new-nucala-administration-options-approved/
- Published: 2019-06-07T12:00:00.000Z
- Updated: 2026-09-15T01:31:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144288

FDA has approved two new methods for administering GlaxoSmithKline’s Nucala (mepolizumab) — an autoinjector and a pre-filled safety syringe — for patients with severe eosinophilic asthma (SEA) or the rare disease eosinophilic granulomatosis with polyangiitis. This is the first anti-IL5 biologic to be licensed in the U.S. for at-home administration, and the first respiratory biologic to be approved for administration with an autoinjector, Glaxo says. The company’s original lyophilized powder version remains available for administration by a healthcare professional.

The approval was supported by patient experience data from two open-label, single-arm, Phase 3 studies (NCT03099096 & NCT03021304) evaluating the real-world use of Nucala administered via the new options in-clinic and at home by patients with SEA, or by their caregivers. “Both studies showed patients were able to successfully self-administer treatment with both the autoinjector and pre-filled syringe after appropriate training (89-95% and 100% respectively),” the company says. “In addition, the majority of patients preferred at home self-administration options compared to in-clinic administration.”