Tokyo-based Japanese pharmaceutical major Takeda has announced recently
that the United States Food and Drug Administration (FDA) has approved
the supplemental Biologics License Application (sBLA) for the expanded
use of lanadelumab-flyo, marketed as Takhzyro, for prophylaxis to
prevent attacks of hereditary angioedema (HAE), characterised by
excessive swelling of abdomen and limbs, in paediatric patients between
aged between two to 12 years.
Pointing out that previously children of HAE under the age of six had no approved prophylaxis treatment, the approval has made Takhzyro the first prophylaxis treatment for this age group.
Additionally, the statement added that for paediatric patients of hereditary angioedema between the ages of six to 12 years of age, the only approved routine prophylaxis required dosing every three to four days.
The recommended dose is 150 mg per one mL solution in a single-dose prefilled syringe every four weeks in patients between two to six years of age and every two weeks in patients between six to 12 years of age.
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Commenting on the approval, said Anthony Castaldo, president and CEO of the U.S. Hereditary Angioedema Association, said. “Today’s approval for Takhzyro in paediatric patients as young as two years of age brings a welcome and important addition to treatment options available for children living with HAE.”
“Today’s approval of the expanded indication of Takhzyro represents a significant step forward for the HAE community as it helps some of its youngest patients who are living with the disease to have a long-term prophylaxis treatment available to them,” Julie Kim, president, U.S. Business Unit and U.S. country head at Takeda said.
It may be noted that the drug was initially approved in the United States in 2018 for prophylaxis to prevent attacks of HAE in adult and paediatric patients 12 years and older and is currently available in more than 60 countries around the world.