Takeda Seeks FDA Approval For Hereditary Angioedema Treatment For Younger Kids

The FDA has accepted Takeda Pharmaceutical Co Ltd's TAK supplemental marketing application for the potential expanded use of TAKHZYRO (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to <12 years of age.
Children with HAE under the age of 6 have no approved prophylaxis treatment. If approved, TAKHZYRO could potentially become the first treatment of its kind for this population.
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The FDA has granted priority review of the application and indicated a decision is expected in the first half of 2023.
The application is based on data from the SPRING study, the first and only open-label Phase 3 trial for HAE patients under 12.
TAKHZYRO is a prescription medicine used to prevent attacks of hereditary angioedema (HAE) in people 12 years and older.
Price Action: TAK shares are down 0.99% at $13.47 on the last check Wednesday.