European Commission approves Hyqvia for chronic inflammatory demyelinating polyneuropathy

Key takeaways:

• Hyqvia is an immune globulin infusion (human) 10% solution.
• It was previously approved by the EC for primary immunodeficiency in 2013.

The European Commission has approved Hyqvia as maintenance therapy for individuals of all ages with chronic inflammatory demyelinating polyneuropathy.

According to a release from Takeda, the approval was based on data from the phase 3 ADVANCE-CIDP 1 trial, a global, multicenter, placebo-controlled, double-blinded study evaluating safety and efficacy of Hyqvia (immune globulin infusion [human] 10% solution with recombinant human hyuralonidase) to prevent relapse in patients with CIDP.

The study included 132 adults with a confirmed diagnosis of CIDP who had remained on a stable dosing regimen of IV immunoglobulin therapy for at least 3 months prior to screening. Results showed a clinically significant reduction in CIDP relapse rate with Hyqvia (15.5% [95% CI; 8.36-26.84]0 compared with placebo (31.7% [95% CI; 21.96-43.39]).

The approval announcement comes on the heels of a positive opinion from the Committee for Medicinal Products for Human Use regarding Hyqvia on Dec. 15, as well as an FDA approval on Jan. 16.

Hyqvia gained initial approval from the European Commission for the treatment of primary immunodeficiency in 2013 as well as secondary immunodeficiency in 2020.

“The [European Commission]’s approval of Hyqvia for [chronic inflammatory demyelinating polyneuropathy] is a critical step towards giving people in the [European Union] living with access to a maintenance treatment with proven efficacy that can be administered up to once monthly, at-home or in-office,” Kristina Allikmets, senior VP and head of research and development for Takeda’s Plasma-Derived Therapies Business Unit, said in the release.