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FDA Expands Approval for Takeda’s Takhzyro

FDA Expands Approval for Takeda’s Takhzyro

The FDA has approved Takeda’s supplemental biologics license application (sBLA) to expand the use of Takhzyro (lanadelumab-flyo) to prevent attacks of hereditary angioedema (HAE) in pediatric patients aged from two to under 12 years old.

Prior to the new approval, the only approved routine prophylaxis treatment options for children from six to under 12 years old required dosing every three to four days.

The drug is given every four weeks in patients from two to under six years of age and every two weeks in patients aged six to under 12 years.

The sBLA approval was supported by extrapolation of efficacy data from a phase 3 trial that included patients 12 to under 18 years old, and additional pharmacokinetic analyses showing similar drug exposures between adults and pediatric patients.

Potentially fatal upper airway angioedema has been reported in HAE patients as young as three years of age.

February 10, 2023


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