The United States Food and Drug Administration (FDA) has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. CIDP is a rare, immune-mediated inflammatory disorder that affects the myelin sheaths, the fatty coverings that insulate and protect peripheral nerve fibers.

In a communiqué, the federal drug agency also stated that patients with CIDP have growing weakness in their arms and legs, numbness and tingling, decreased balance, and difficulties walking. The illness usually affects people in their 50s and 60s, and it is more prevalent in men.

Researchers have found that Vyvgart Hytrulo, previously licensed for treating generalised myasthenia gravis (gMG) in adults with anti-acetylcholine receptor (AChR) antibodies, is also effective in treating CIDP. The approval was based on a two-stage, multicenter study (research 3; NCT04281472) that had a period of open labelling to find people who responded and then a phase of randomization, double blinding, placebo control, and withdrawal.

221 individuals received weekly subcutaneous injections of either Vyvgart Hytrulo (n = 111) or placebo (n = 110) during the withdrawal period. Patients treated with Vyvgart Hytrulo had a statistically significant longer time to clinical deterioration compared to those given a placebo.

However, Vyvgart Hytrulo may raise the risk of infections, including urinary and respiratory tract infections. Hypersensitivity responses identified in clinical studies included rash, angioedema (swelling), dyspnea (shortness of breath), and urticaria (itchy welts). The frequency of adverse reactions in CIDP patients was comparable to that in gMG patients, with common side effects including respiratory tract infections, headaches, and urinary tract infections. In addition, injection site responses occurred in more than 15% of CIDP patients treated with Vyvgart Hytrulo.

Vyvgart Hytrulo's approval provides a new therapy option for individuals suffering from CIDP, raising hopes for better management of this painful ailment.