15.12.2023 14:48:58

Takeda: CHMP Recommends Approval Of HYQVIA

(RTTNews) - Takeda (TAK) announced the European Medicines Agency's Committee for Medicinal Products for Human Use has recommended the approval of HYQVIA in patients with chronic inflammatory demyelinating polyneuropathy as maintenance therapy after stabilization with intravenous immunoglobulin therapy. The company said the proposed extension of indication for HYQVIA is based on data from the Phase 3 ADVANCE-CIDP 1 clinical trial.

Takeda noted that HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with chronic inflammatory demyelinating polyneuropathy.

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