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Takhzyro Approval History

FDA Approved: Yes (First approved August 23, 2018)
Brand name: Takhzyro
Generic name: lanadelumab-flyo
Dosage form: Injection
Company: Shire plc
Treatment for: Hereditary Angioedema

Takhzyro (lanadelumab-flyo) is a plasma kallikrein inhibitor (monoclonal antibody) for the prevention of angioedema attacks in patients with hereditary angioedema.

Development History and FDA Approval Process for Takhzyro

DateArticle
Aug 23, 2018Approval FDA Approves Takhzyro (lanadelumab-flyo) for Hereditary Angioedema
Feb 23, 2018FDA Accepts Shire’s Biologics License Application (BLA) and Grants Priority Review for Lanadelumab for the Prevention of Attacks in Hereditary Angioedema (HAE) Patients
May 18, 2017Shire’s Investigational Treatment Lanadelumab Reduces Hereditary Angioedema Monthly Attack Rate by 87% Versus Placebo in Phase 3 26-week Pivotal Trial

Further information

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