FDA approves Vyvgart for chronic inflammatory demyelinating polyneuropathy
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The FDA has approved Vyvgart Hytrulo in a once-weekly, 30- to 90-second subcutaneous injection to treat adults with chronic inflammatory demyelinating polyneuropathy, according to the manufacturer.
Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is the first and only neonatal Fc receptor (FcRn) blocker approved for the treatment of the rare, debilitating neuromuscular condition, argenx said in a press release.
“The FDA approval of Vyvgart Hytrulo marks a significant advancement for patients and healthcare providers, who now have a safe, effective, and less burdensome option for treating [chronic inflammatory demyelinating polyneuropathy]," Luc Truyen MD, PhD, chief medical officer, argenx, told Healio in an email.
Approval was based on the multicenter, randomized, double-blind, placebo controlled ADHERE study, in which 221 of 322 patients treated with Vyvgart Hytrulo demonstrated evidence of clinical improvement including mobility, motor function and muscle strength. ADHERE additionally met its primary endpoint in showing significant reduction in risk of relapse compared with placebo, while its safety profile was consistent with previous clinical trials featuring the therapeutic as well as real-world use, according to the release.
Patients with chronic inflammatory demyelinating polyneuropathy (CIDP) experience a range of disabling mobility and sensory issues, including trouble standing from a seated position, pain, fatigue and difficulty remaining upright. Many patients become wheelchair bound and are unable to work as the disease progresses, with 85% of individuals with the condition requiring ongoing treatment.
In December 2021, Vyvgart Hytrulo was approved by the FDA to treat generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor (AChR) antibody positive. An injectable formulation was subsequently approved in June 2023.
Editor's note: This story was updated on June 27, 2024 to include a quote from argenx chief medical officer.