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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
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

Further information

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