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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