A decade after its first FDA approval, Takeda expands label of HyQvia to include rare autoimmune disorder

The FDA on Mon­day ex­tend­ed the la­bel for Take­da’s HyQvia (im­mune glob­u­lin in­fu­sion 10% [hu­man] with re­com­bi­nant hu­man hyaluronidase) as a main­te­nance ther­a­py to pre­vent the re­lapse of neu­ro­mus­cu­lar dis­abil­i­ty and im­pair­ment in adults with the rare au­toim­mune dis­or­der known as chron­ic in­flam­ma­to­ry de­myeli­nat­ing polyneu­ropa­thy (CIDP).

HyQvia, ac­quired as part of Take­da’s $62 bil­lion takeover of rare dis­ease spe­cial­ist Shire in 2019, can now be in­fused up to once month­ly (every two, three or four weeks), Take­da said. The com­pa­ny not­ed that it can be ad­min­is­tered by a health­care pro­fes­sion­al in a med­ical of­fice, in­fu­sion cen­ter or at a pa­tient’s home, or it can be self-ad­min­is­tered af­ter ap­pro­pri­ate pa­tient or care­giv­er train­ing.

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