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# Vyvgart Hytrulo OK’d for Demyelinating Polyneuropathy
- URL: https://www.fdaweb.com/vyvgart-hytrulo-okd-for-demyelinating-polyneuropathy/
- Published: 2024-06-24T12:00:00.000Z
- Updated: 2026-09-14T14:34:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157233

FDA has approved Halozyme Therapeutics’ Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for treating chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Previously, the product was approved for treating adults with generalized myasthenia gravis who are anti-acetylcholine receptor antibody positive.

CIDP is a rare immune-mediated, inflammatory, peripheral nerve disorder that affects the myelin sheaths, which are the fatty coverings on the fibers that insulate and protect the nerves, according to an [FDA release](https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-chronic-inflammatory-demyelinating-polyneuropathy-cidp-adults?utm%5Fmedium=email&utm%5Fsource=govdelivery). Symptoms include progressive weakening of the arms and legs, numbness and tingling, impaired balance, and difficulty walking.

Approval is based on data from the company’s study ([Study 3; NCT04281472](https://www.clinicaltrials.gov/study/NCT04281472?cond=NCT04281472&rank=1&ref=fdaweb.com)) showing that patients who received Vyvgart Hytrulo experienced a longer time to clinical deterioration than patients who received placebo, FDA says. Regarding safety, it says Vyvgart Hytrulo may increase the risk of infection, including urinary tract infection and respiratory tract infections. In clinical trials, hypersensitivity reactions, including rash, angioedema, dyspnea, and urticaria (itchy welts) were observed in patients treated with Vyvgart Hytrulo.