- Halozyme Therapeutics (HALO, Financial) announces positive CHMP opinion for argenx's VYVGART® (efgartigimod alfa) with ENHANZE® for CIDP treatment.
- The European Commission's decision, expected within two months, could authorize use across 30 European countries.
- VYVGART represents the first novel CIDP treatment mechanism in over 30 years, backed by the ADHERE clinical trial.
Halozyme Therapeutics, Inc. (HALO) has reported that argenx has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency. This recommendation suggests approval by the European Commission for VYVGART® 1000mg, a subcutaneous injection developed with ENHANZE®, to treat adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP).
The treatment is designed for those with progressive or relapsing active CIDP after prior treatments with corticosteroids or immunoglobulins. VYVGART, available in vial or prefilled syringe form, is the first targeted IgG Fc-antibody fragment for this condition and introduces a novel mechanism of action not seen in more than 30 years.
This recommendation follows the results of the ADHERE clinical trial, noted as the largest study of CIDP patients to date. The forthcoming decision from the European Commission, expected within two months, will apply to all 27 EU Member States, as well as Iceland, Norway, and Liechtenstein.
The potential approval of VYVGART with ENHANZE could significantly expand Halozyme's market presence in Europe, offering a groundbreaking treatment option for CIDP. The convenience of self-administration by patients or caregivers could enhance its adoption over existing therapies.
