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Takhzyro FDA 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 timeline for Takhzyro

DateArticle
Feb  3, 2023Approval U.S. FDA Approves Takeda’s Takhzyro (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks in Children 2 Years of Age and Older
Feb  9, 2022Approval Takeda Receives U.S. FDA Approval for Prefilled Syringe Presentation of Takhzyro (lanadelumab-flyo) for Use as a Preventive Treatment for Hereditary Angioedema Attacks
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

See also

Takhzyro (lanadelumab-flyo) Consumer information

Further information

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