The recommendation will be considered by the European Commission in deciding whether to allow Hyqvia for CIDP to be marketed across the European Union
Takeda’s global hub in Cambridge, Massachusetts, US. (Credit: Takeda Pharmaceutical Company Limited)
Takeda has received the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) positive opinion for Hyqvia approval as maintenance therapy in patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
Hyqvia [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] is a liquid therapy that contains recombinant human hyaluronidase and immunoglobulins (Ig).
CHMP has recommended Hyqvia after stabilisation with intravenous immunoglobulin therapy (IVIG).
The recommendation will be considered by the European Commission (EC) in deciding whether to allow Hyqvia for CIDP to be marketed across the European Union.
When approved, the therapy will offer a once-monthly option for facilitated subcutaneous at-home or in-office treatment.
Takeda plasma-derived therapies business unit research and development SVP and head Kristina Allikmets said: “Takeda is focused on bringing its differentiated immunoglobulin therapies to patients with neuro-immunological disorders, providing treatment options that address the needs of a broad range of patients.
“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 personalisation through up to once-monthly facilitated subcutaneous administration at home or in office.”
This proposed extension of indication for Hyqvia is supported by results from the Phase 3 multicentre, placebo-controlled, double-blinded ADVANCE-CIDP 1 clinical study.
It assessed the efficacy, safety and tolerability of Hyqvia as maintenance therapy in adult CIDP patients.
The trial met its primary endpoint demonstrating a statistically significant reduction in relapse rate.
In the US, the therapy is also undergoing regulatory assessment for use as a maintenance treatment in adult CIDP patients.
EMA has authorised Hyqvia as replacement therapy for primary immunodeficiency (PI) and secondary immunodeficiency (SID).
Additionally, the drug is approved in the US for the treatment of adults and children two years of age and older with PI.