FDA greenlights new indication for Takeda's Takhzyro

The US Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged two to <12 years, Japanese pharma giant Takeda (TYO: 4502) announced over the weekend.

Takhzyro received its first approval for the drug in the USA in 2018 to prevent HAE attacks in patients 12 years and older.

Prior to this latest authorization, the only approved routine prophylaxis treatment options for children six to <12 years of age required dosing every three to four days, and children with HAE two to