Takeda Seeks FDA Approval For Hereditary Angioedema Treatment For Younger Kids

The FDA has accepted Takeda Pharmaceutical Co Ltd's (NYSE: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.