Take­da is head­ing to the FDA with pos­i­tive PhI­II re­sults for HyQvia in rare au­toim­mune dis­ease

Eight years in­to its mar­ket­ing odyssey, Take­da says it’s ready to pitch HyQvia for a new in­di­ca­tion.

Late last week Take­da — which wound up with the drug from its Shire buy­out — re­port­ed suc­cess­ful re­sults of its Phase III clin­i­cal tri­al for its drug as a main­te­nance ther­a­py for a rare au­toim­mune dis­or­der, chron­ic in­flam­ma­to­ry de­myeli­nat­ing polyradicu­loneu­ropa­thy (CIDP). And its re­search team be­lieves HyQvia is ready to win ap­proval for this la­bel add.

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