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# Shire’s Takhzyro Approved for Hereditary Angioedema
- URL: https://www.fdaweb.com/shires-takhzyro-approved-for-hereditary-angioedema/
- Published: 2018-08-27T12:00:00.000Z
- Updated: 2026-09-15T00:28:15.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142203

FDA has approved a Shire BLA for Takhzyro (lanadelumab-flyo) injection for preventing hereditary angioedema (HAE) attacks in patients 12 years of age and older. HAE is a rare, genetic and potentially life-threatening disorder that can result in recurrent swelling attacks in various parts of the body. The company says that Takhzyro is the only monoclonal antibody that provides targeted inhibition of plasma kallikrein, an enzyme which is chronically uncontrolled in people with HAE, to help prevent attacks.

Approval is based on data from the Phase 3 HELP (Hereditary Angioedema Long-term Prophylaxis) Study that showed the therapy reduced the number of monthly HAE attacks an average of 87% vs. placebo when administered at 300 mg every two weeks and 73% vs placebo when administered at 300 mg every four weeks. The most commonly observed adverse reactions associated with Takhzyro were injection site reactions consisting mainly of pain, erythema, and bruising at the injection site; upper respiratory infection; headache; rash; myalgia; dizziness; and diarrhea, the company says.