FDA approves Vyvgart Hytrulo for chronic inflammatory demyelinating polyneuropathy

The U.S. Food and Drug Administration has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) to treat chronic inflammatory demyelinating polyneuropathy (CIDP), an acquired immune-mediated inflammatory disorder of the peripheral nervous system. This is the first neonatal Fc receptor (FcRn) blocker approved for CIDP.

The approval is based on positive results from the ADHERE study. In the study, 69% of patients showed clinical improvement in mobility, function, and strength. The primary endpoint was met, showing a 61% reduction in relapse risk compared to placebo. Almost all participants joined the open-label extension. Hytrulo is administered as a weekly subcutaneous injection, representing a significant advancement in CIDP treatment.

“Today marks a groundbreaking day for the treatment of CIDP. 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,” said Jeffrey Allen, MD, Professor, Department of Neurology, University of Minnesota and Principal Investigator in the ADHERE trial in a press release. “Today’s approval of Vyvgart Hytrulo gives doctors and patients a new, safe and effective treatment option that may lessen the burden of treatment that some patients experience.”

The full press release can be found here.