Takeda snags expanded pediatric approval for rare genetic disorder drug
The FDA on Friday approved Takeda’s supplement to expand the use of Takhzyro, a hereditary angioedema (HAE) drug acquired as part of its $62 billion Shire deal, to children ages 2 to 12.
The prophylactic monoclonal antibody is meant to prevent attacks of HAE, which can be painful, with severe swelling.
The single-dose prefilled syringe is recommended every four weeks in patients ages 2 to <6 and every two weeks in patients ages 6 to <12, according to the company. Takhzyro first won FDA approval in 2018 for patients 12 years and older.
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