Takeda (TSE:4502/NYSE:TAK) today 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). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for HYQVIA for CIDP throughout the European Union.
“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.
About HYQVIA®
HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid medicine containing Recombinant Human Hyaluronidase and immunoglobulins (Ig) and is approved by the European Medicines Agency (EMA) as a replacement therapy in adults, children and adolescents with primary immunodeficiency (PI) and with secondary immunodeficiency (SID) who suffer from severe or recurrent infections, ineffective antimicrobial treatment, and either proven specific antibody failure (PSAF) or serum IgG level of <4 g/L. It is also approved in the United States to treat adults and children two years of age and older with PI. HYQVIA is infused under the skin into the fatty subcutaneous tissue. HYQVIA contains immunoglobulins collected from human plasma. Immunoglobulins are antibodies that maintain the body’s immune system. The hyaluronidase part of HYQVIA helps more of the Ig get absorbed into the body. HYQVIA is infused up to once a month (every three or four weeks).
