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# FDA Accepts Shire Lanadelumab BLA for Filing
- URL: https://www.fdaweb.com/fda-accepts-shire-lanadelumab-bla-for-filing/
- Published: 2018-02-23T12:00:00.000Z
- Updated: 2026-09-14T23:24:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140838

FDA has accepted Shire’s BLA for lanadelumab and will give it a priority review for preventing angioedema attacks in patients age 12 and older with hereditary angioedema (HAE), a rare genetic disorder. The company says that if it is approved, lanadelumab will be the first monoclonalantibody for HAE, a serious and potentially life threating disease. It provides a new mechanism of action, inhibiting plasma kallikrein to prevent HAE attacks.

Shire says the BLA is supported by data from four clinical trials.

Lanadelumab is described as an investigational fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein. It is formulated for subcutaneous administration, and has a half-life of approximately 14 days in patients with HAE.