FDA OKs Vyvgart Hytrulo for CIDP

The US Food and Drug Administration (FDA) has approved the combination of efgartigimod alfa and hyaluronidase-qvfc (Vyvgart Hytrulo, argenx) for treatment of adults with chronic inflammatory demyelinating polyneuropathy (CIDP), a rare and often debilitating autoimmune disorder. 

Efgartigimod alfa–hyaluronidase is the first neonatal Fc receptor blocker approved for the treatment of CIDP and will be available as a once-weekly 30- to 90-second subcutaneous injection.

In the phase 3 ADHERE study, 69% of patients treated with the drug, regardless of prior treatment, showed evidence of clinical improvement, including improvement in mobility, function, and strength, the company noted in a news release announcing US approval. 

The study met its primary endpoint demonstrating a 61% reduction (hazard ratio [HR], 0.39; P < .0001) in the risk for relapse vs placebo, with 99% of study participants opting to participate in the ADHERE open-label extension. 

The safety results were generally consistent with the known safety profile of efgartigimod alfa (Vyvgart) in previous clinical studies and real-world use, the company said. 

“The approval of this promising new treatment option for CIDP may provide hope to patients that they can treat their disease beyond just managing symptoms. CIDP patients deserve treatment options and we look forward to a future of choices for optimal and individualized care,” Lisa Butler, executive director, GBS/CIDP Foundation, said in the news release.

This approval marks a “groundbreaking day for the treatment of CIDP,” added Jeffrey Allen, MD, principal investigator in the ADHERE trial and professor, Department of Neurology, University of Minnesota, Minneapolis.

“Existing treatments for CIDP 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 Allen. 

The 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,” Allen added. 

Vyvgart Hytrulo is also approved in the United States for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody–positive.