Takeda (TYO: 4502) has secured European approval for Hyqvia (immune globulin) as maintenance therapy for people with chronic inflammatory demyelinating polyneuropathy (CIDP).
The decision was made based on data from the Phase III ADVANCE-CIDP 1 trial, which showed a clinically-significant reduction in CIDP relapse rate, compared with placebo.
Senior vice president Kristina Allikmets said the nod was “a critical step towards giving people in the EU living with CIDP access to a maintenance treatment with proven efficacy that can be administered up to once monthly, at-home or in-office.”
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