Halozyme Therapeutics Inc (NASDAQ:HALO) announced on Friday that Dutch immunology company argenx SE (Euronext Brussels:ARGX) (Nasdaq:ARGX) has received European Commission approval for VYVGART 1000mg (efgartigimod alfa) developed with ENHANZE, Halozyme's proprietary recombinant human hyaluronidase enzyme (rHuPH20), for subcutaneous (SC) injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior treatment with corticosteroids or immunoglobulins.

VYVGART is the first and only targeted IgG Fc-antibody fragment for CIDP and the first novel mechanism of action for CIDP treatment in more than 30 years.

The Commission's decision was based on positive results from the ADHERE clinical trial, the largest study of CIDP patients to date.

The approval is valid in all 27 European Union member states, as well as Iceland, Norway and Liechtenstein.