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# FDA Approves Expanded Use for Glaxo’s Nucala
- URL: https://www.fdaweb.com/fda-approves-expanded-use-for-glaxos-nucala/
- Published: 2017-12-12T12:00:00.000Z
- Updated: 2026-09-14T23:07:34.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140324

FDA has expanded the approved use of GlaxoSmithKline’s Nucala (mepolizumab) to treat adult patients with eosinophilic granulomatosis with polyangiitis (EGPA), a rare autoimmune disease that causes vasculitis. Formerly, EGPA was known as Churg-Strauss syndrome, a condition characterized by asthma, high levels of eosinophils (a type of white blood cell that helps fight infection), and inflammation of small- to medium-sized blood vessels. The inflamed vessels can damage various organ systems including the lungs, gastrointestinal tract, skin, heart and nervous system, an FDA [news release ](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm588594.htm?ref=fdaweb.com)says.

Nucala was originally[ approved in 2015](https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm471031.htm?ref=fdaweb.com) to treat patients age 12 years and older for severe asthma with an eosinophilic phenotype. The interleukin-5 antagonist monoclonal antibody is produced by recombinant DNA technology in Chinese hamster ovary cells, FDA says. It is administered once every four weeks by subcutaneous injection.

Expanded approval was based on data from a 52-week treatment clinical trial that compared Nucala to placebo. “Patients receiving 300 mg of Nucala achieved a significantly greater accrued time in remission compared with placebo,” the agency says. “A significantly higher proportion of patients receiving 300 mg of Nucala achieved remission at both week 36 and week 48 compared with placebo. The most common adverse reactions associated with Nucala in clinical trials included headache, injection site reaction, back pain, and fatigue.”