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# Takeda sBLA for Takhzyro Expanded Indication
- URL: https://www.fdaweb.com/takeda-sbla-for-takhzyro-expanded-indication/
- Published: 2023-02-06T12:00:00.000Z
- Updated: 2026-09-14T18:14:47.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5153709

FDA has approved a Takeda supplemental BLA for an expanded use of Takhzyro (lanadelumab-flyo) — prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to 11 years of age. Previously, the drug was approved for prophylaxis treatment in adults and children aged six to 11 years.

The approval was based on data extrapolated from the HELP Study, a Phase 3 trial that included patients 12 to 17 years of age, and additional pharmacokinetic analyses showing similar drug exposures between adults and pediatric patients, according to the company. It also relied on safety and pharmacodynamic data from the [SPRING Study](https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.takeda.com%2Fnewsroom%2Fnewsreleases%2F2022%2Fphase-3-spring-study-data-presented-at-eaaci%2F&esheet=53302089&newsitemid=20230203005431&lan=en-US&anchor=SPRING+Study&index=2&md5=c1ae6992862ee9f708b86bef2de1943e&ref=fdaweb.com), an open-label Phase 3 trial in 21 HAE patients 2 to 11 years of age.

Takhzyro is described as a human monoclonal antibody that decreases plasma kallikrein activity.