Biotech firm argenx (Flanders) treats rare muscle disease

Another milestone on the track record of Flanders’ life sciences scene! In December 2021, the US Food & Drug Administration (FDA) gave the green light for the commercialization of a new medicine by argenx, a biotech firm originally from Ghent (Flanders). The new drug, called VYVGART, can now be used for the treatment of generalized myasthenia gravis, a rare chronic autoimmune neuromuscular disease that causes weakness in the skeletal muscles.

Dedicated investments

After more than 10 years of hard work and approximately EUR 1 billion of R&D investments, the time has finally come. The US Food & Drug Administration has allowed argenx to commercialize its treatment on the American market. In the years prior to the FDA approval, the new medicine was referred to as “efgartigimod.” Now, it has received its final name: VYVGART.It will be used for the treatment of generalized myasthenia gravis (gMG) in adult patients who test positive for the anti-acetylcholine receptor (AChR) antibody. These patients represent around 85% of the total gMG population.

“We are thrilled. This is a historic moment: a milestone for patients and argenx. Our research started long ago under the name ARGX-113 and is now receiving FDA approval as VYVGART: the result of hard work, innovation and collaboration over the past decade.” Tim Van Hauwermeiren, CEO of argenx

A triple first

The approval of VYVGART represents not one but three firsts for argenx. Not only is it the company’s first approved product; it is also the first (and currently only) FDA-approved neonatal Fc receptor blocker. What’s more, the medicine is the first-ever approved therapy designed to reduce pathogenic IgG antibodies, which are an underlying driver of gMG.“Importantly,” argenx CEO Tim Van Hauwermeiren adds, “we want to thank the patients, supportive caregivers, investigators and study teams who participated in the ADAPT trial, as well as our partners and dedicated employees for their hard work and collaboration – all of them made this milestone possible.”

Stringent testing

The safety and efficacy of VYVGART were thoroughly evaluated by the FDA in a 26-week clinical study where 167 patients with myasthenia gravis received either VYVGART or a placebo. The findings showed that more myasthenia gravis patients with antibodies responded to treatment during the first cycle of VYVGART (68%) compared to those who received a placebo (30%). In addition, more patients receiving VYVGART demonstrated response on a measure of muscle weakness compared to patients receiving a placebo.

“There are significant unmet medical needs for people living with myasthenia gravis, as with many other rare diseases. The approval of VYVGART is a major step in providing a new therapy option for patients and underscores our commitment to help make new treatment options available for people living with rare diseases.” Billy Dunn, director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation & Research

“The gMG community has long awaited the FDA approval of VYVGART, especially for patients struggling with basic personal tasks such as speaking, chewing, swallowing, brushing their teeth, and in some severe cases, breathing. We thank argenx for its continued commitment to the gMG patient community, which led them to deliver this much-needed new treatment option. It has the potential to change many lives.” Samantha Masterson, President and CEO of the Myasthenia Gravis Foundation of America, Inc.

A revolution in the making

Analysts assume that VYVGART’s annual sales will increase to more than USD 5 billion, assuming that the drug can also be used for other rare diseases. Currently, argenx has plans to evaluate the new treatment in at least 15 disease areas by 2025.

“This is just the beginning. We see a future for argenx with exponential growth. We are on the verge of a revolution in the world of autoimmune diseases.” Tim Van Hauwermeiren, CEO of argenx

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