FDA Approves Argenx Vyvgart Hytrulo for CIDP

Rare Daily Staff

The U.S. Food and Drug Administration expanded the indication for Argenx’s Vyvgart Hytrulo to include chronic inflammatory demyelinating polyneuropathy, a rare, autoimmune disorder.

Vyvgart Hytrulo is approved for CIDP as a once weekly 30-to-90 second subcutaneous injection. It is the first and only neonatal Fc receptor blocker approved for the treatment of CIDP.

“Patients have been waiting, and today Argenx is delivering the first innovative treatment for CIDP in more than 30 years,” said Luc Truyen, chief medical officer of Argenx. “Vyvgart Hytrulo is a precision tool that has been shown to drive meaningful benefits for patients.”

Chronic inflammatory demyelinating polyneuropathy (CIDP) is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. Patients experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain and fatigue, and frequent tripping or falling. Many patients become wheelchair bound and are unable to work as the disease progresses. Currently, 85 percent of patients require ongoing treatment and nearly 88 percent of treated patients experience residual impairment and disability.

Vyvgart Hytrulo is a subcutaneous combination of efgartigimod alfa, a human IgG1 antibody fragment marketed for intravenous use as Vyvgart, and recombinant human hyaluronidase PH20, Halozyme’s Enhanze drug delivery technology to facilitate subcutaneous injection delivery of biologics. In binding to the neonatal Fc receptor (FcRn), Vyvgart Hytrulo results in the reduction of circulating IgG. The U.S. Food and Drug Administration approved Vyvgart Hytrulo in June 2023 to treat patients with generalized myasthenia gravis.

“Today marks a groundbreaking day for the treatment of CIDP,” said Jeffrey Allen, professor in the Department of Neurology and the University of Minnesota and principal investigator in the ADHERE trial. “Existing treatments have been limited to corticosteroids and plasma-derived therapies. These treatments, while effective for many patients, can be challenging for some patients to receive.”

The FDA approval is based on the ADHERE Study, the largest clinical trial to date studying CIDP. In the ADHERE study, 69 percent of patients treated with Vyvgart Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function, and strength.