Halozyme (HALO) Therapeutics announced that argenx received a positive opinion from the Committee for Medicinal Products for Human Use of the European Medicines Agency recommending European Commission approval of VYVGART developed with ENHANZE, Halozyme’s proprietary recombinant human hyaluronidase enzyme for subcutaneous injection as a monotherapy for the treatment of adult patients with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy after prior treatment with corticosteroids or immunoglobulins. The SC injection of VYVGART is available as a vial or prefilled syringe and can be administered by a patient, caregiver, or healthcare professional. VYVGART is the first and only targeted IgG Fc-antibody fragment for Chronic Inflammatory Demyelinating Polyneuropathy and the first novel mechanism of action for CIDP treatment in more than 30 years.
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