Japan’s Takeda Pharmaceutical Co. Ltd. (TAK,TKPHF.PK) announced Wednesday that the U.S. Food & Drug Administration has accepted a supplemental Biologics License Application or sBLA for use of TAKHZYRO (lanadelumab-flyo) for prophylaxis to prevent hereditary angioedema or HAE attacks in children 2 years of age and older.
HAE is a rare genetic disorder that results in recurring attacks of edema – swelling – in various parts of the body, including the abdomen, face, feet, genitals, hands and throat.
TAKHZYRO is a prescription medicine used to prevent attacks of HAE in people 12 years of age and older. It is not known if TAKHZYRO is safe and effective in children under 12 years of age.
At present, 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 in pediatric patients 2 to <12 years of age.
The FDA has granted priority review of the application and indicated a decision is expected in the first half of 2023.
The sBLA is based on data from the SPRING study, the first and only open-label Phase 3 trial for HAE patients under the age of 12.
If approved, children in the U.S. would have access to treatment for the prevention of HAE attacks that can involve serious and severely debilitating swelling in the abdomen, face, feet, genitals, hands and throat.
Currently, TAKHZYRO is approved and available in more than 30 countries around the world.
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