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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