FDA approves treatment for chronic inflammatory demyelinating polyneuropathy (CIDP) in adults

Action

The U.S. Food and Drug Administration has approved Vyvgart Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) for the treatment of chronic inflammatory demyelinating polyneuropathy (CIDP) in adults. Vyvgart Hytrulo is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase. Vyvgart Hytrulo was previously approved for the treatment of adults with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive.

For CIDP, Vyvgart Hytrulo is administered subcutaneously (under the skin) as weekly injections. The recommended dose is detailed in the prescribing information.

Disease or Condition

CIDP is a rare type of immune-mediated, inflammatory, peripheral nerve disorder that affects the myelin sheaths - the fatty coverings on the fibers that insulate and protect the nerves.

Symptoms of CIDP include progressive weakening of the arms and legs, numbness and tingling, impaired balance, and difficulty walking. CIDP can occur in anyone, but people in their 50s and 60s seem more likely to develop the disorder than people in other age groups. CIDP is more common in men than in women.

Effectiveness

The effectiveness of Vyvgart Hytrulo for the treatment of adults with CIDP was established in a two stage, multicenter study (Study 3; NCT04281472). Study 3 included an open-label period (stage A) to identify patients who had evidence of improvement with the use of Vyvgart Hytrulo, who then entered a randomized, double-blind, placebo-controlled, withdrawal period (stage B).

In stage B, a total of 221 patients were randomized to receive weekly subcutaneous injections of Vyvgart Hytrulo (n=111) or placebo (n=110). Patients who received Vyvgart Hytrulo experienced a longer time to clinical deterioration compared to patients who received placebo, which was statistically significant. 

Safety Information

Vyvgart Hytrulo may increase the risk of infection, including urinary tract infection and respiratory tract infections. In clinical trials, hypersensitivity reactions, including rash, angioedema (swelling), dyspnea (shortness of breath), and urticaria (itchy welts) were observed in patients treated with Vyvgart Hytrulo.

The rate of adverse reactions of Vyvgart Hytrulo in patients with CIDP was similar to those in patients with gMG who were treated with Vyvgart. The most common adverse reactions (≥ 10%) of patients with gMG treated with Vyvgart were respiratory tract infections, headache, and urinary tract infection.

Injection site reactions were also present (≥ 15%) in patients with CIDP who were treated with Vyvgart Hytrulo.

See full prescribing information for additional information on risks associated with Vyvgart Hytrulo.

Source from FDA:https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-treatment-chronic-inflammatory-demyelinating-polyneuropathy-cidp-adults

RTU(ready to use) 2ml COP vial

Polymer Vial for cell and gene therapies