Takeda Gets Positive CHMP Opinion for HYQVIA® in CIDP Maintenance Therapy

15 December 2023 | Friday | News

The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.

  • If Approved, HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Would Offer an up to Once-Monthly Facilitated Subcutaneous At-Home or In-Office Treatment Option
  • Positive Opinion Based on Phase 3 ADVANCE-CIDP 1 Study, Which Met its Primary Endpoint Demonstrating a Statistically Significant Reduction in Relapse Rate 1

Takeda (TSE:4502/NYSE:TAK announced the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy after stabilization with intravenous immunoglobulin therapy (IVIG). 


“Takeda is focused on bringing its differentiated immunoglobulin therapies to patients with neuroimmunological disorders, providing treatment options that address the needs of a broad range of patients,” said Kristina Allikmets, senior vice president and head of Research & Development for Takeda’s Plasma-Derived Therapies Business Unit. “This positive CHMP opinion is a crucial step towards bringing patients with CIDP and their caregivers an effective therapy that, if approved, may offer maintenance treatment personalization through up to once-monthly facilitated subcutaneous administration at home or in office.”

CIDP is an acquired, immune-mediated condition affecting the peripheral nervous system that is characterized by progressive, symmetric weakness in distal and proximal limbs and impaired sensory function in extremities.2 The role of IGs as maintenance therapy for this rare, debilitating and slowly progressing or relapsing disease has been well-established and is considered a standard of care for this complex and heterogeneous condition in guidelines from the European Academy of Neurology and Peripheral Nerve Society due to its broad immunomodulatory and anti-inflammatory effects.3,4 However, the high volume and frequency of treatment required to effectively manage this disease means that treatment can be a challenge for patients and their health care providers.

This proposed extension of indication for HYQVIA is based on data from the pivotal Phase 3 ADVANCE-CIDP 1 clinical trial, which investigated HYQVIA as maintenance therapy in adult patients with CIDP.

HYQVIA is also under regulatory review in the United States for use as a maintenance therapy in adult patients with CIDP.




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