Argenx’s Vyvgart Hytrulo snares 2nd US nod as FDA gives green light in autoimmune disease CIDP

Fierce Pharma June 21, 2024
Fraiser Kansteiner

For more than a decade, argenx has sought to apply its novel antibody fragment treatment approach to various autoimmune diseases.

Its vision started to come into focus two and a half years ago with the FDA approval for Vyvgart in generalized myasthenia gravis (gMG). Now, the drug has won approval to treat its second indication in the U.S. and its third globally after the U.S. FDA cleared the med to treat the rare and debilitating peripheral nervous system disease chronic inflammatory demyelinating polyneuropathy (CIDP).

Late Friday, the FDA cleared the way for Argenx’s Vyvgart Hytrulo—the Halozyme-partnered subcutaneous version of its inaugural med Vyvgart (efgartigimod)—in CIDP. The drug has been approved as a weekly 30-90-second injection.

The green light...

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