Argenx’ Vyvgart Hytrulo wins second FDA approval

The Food and Drug Administration (FDA) has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP), said Dutch immunology company argenx (Euronext: ARGX), whose shares shot up 8.4% to 402.90 euros by late morning today.

The drug is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of CIDP.

Vyvgart Hytrulo’s approval follows clearances earlier this year for Japanese pharma major Takeda’s (TYO: 4502) HyQvia (immune globulin infusion 10% [human] with recombinant human hyaluronidase) as maintenance therapy.