Argenx's Vyvgart Hytrulo snares 2nd US nod as FDA gives green light in autoimmune disease CIDP
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 marks a breakthrough after three decades of “very little meaningful innovation” in the disease, Susan Begelman, M.D., argenx's VP of global medical affairs & evidence generation, said on a media call.
CIDP is a rare autoimmune disease of the peripheral nervous system that causes fatigue, muscle weakness and loss of feeling in patients’ arms and legs. That weakness can worsen over time or come and go, with the potential for symptoms to significantly impair a person’s ability to function day-to-day. Without treatment, one-third of people living with CIDP will need a wheelchair, argenx has previously pointed out.
Historically, the treatment toolbox for CIDP consisted of steroids, intravenous (IV) or subcutaneous (subQ) immunoglobulins or plasma exchanges, Begelman explained. Takeda, for its part, recently won a U.S. CIDP approval for its subcutaneous immune globulin treatment HyQvia in January
Even still, given that many people with CIDP experience residual symptoms, argenx’s research has found that more than half of CIDP patients report being either somewhat or completely dissatisfied with their symptoms. In turn, these patients continue to seek novel treatment options.
While the presumed autoimmune nature of the CIDP is not fully understood, it’s hypothesized that the disease is caused by autoantibodies—immunoglobulin molecules that are directed or targeted against the myelin coating and certain other proteins that surround the axon or the nerve fiber. The nerve fibers are responsible for sending electrical signals throughout the body.
Vyvgart Hytrulo’s latest approval is based on results from the late-stage ADHERE study—the largest ever performed in CIDP patients, according to Guptill—which found that 69% of patients responded to Vyvgart. At the same time, the drug helped slash patients’ risk of relapse by 61% compared with placebo. Hytrulo was also linked to a fast onset of action, with 40% of patients responding to the therapy by the study’s four-week mark.
June 24, 2024
