European Commission OKs Vyvgart for AChR-positive Generalized MG

The therapy, also approved in US and Japan, had positive results in a Phase 3 trial

Marisa Wexler, MS avatar

by Marisa Wexler, MS |

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The European Commission has approved Vyvgart (efgartigimod) as an add-on to standard treatment for adults with generalized myasthenia gravis (gMG) who are positive for antibodies against acetylcholine receptor (AChR), the most common type of MG-driving antibody.

“We share the excitement with the European gMG community in bringing a new treatment option to those who need it,” said Kathy Perez, head of global patient advocacy and policy at Argenx, the company that developed Vyvgart, in an emailed statement to Myasthenia Gravis News. “We’re eager to deliver this first-in-class therapy to patients as it becomes available in each Member State, and look forward to continued collaboration with the community to raise awareness of this debilitating disease.”

The approval, which follows a positive recommendation from regulators earlier this year, applies to all 27 EU member states, as well as Iceland, Norway, and Liechtenstein. Argenx also announced it will work with local authorities to make Vyvgart available in European markets.

“Now, for the first time, people living with gMG in the EU will have a treatment option that is targeted to the biology of their disease, well-tolerated, and effective in managing symptoms,” Tim Van Hauwermeiren, Argenx’s CEO, said in a press release.

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“We are also committed to supporting broad access to our innovative therapy, and look forward to collaborating with local health authorities to secure sustainable access agreements so we can help alleviate the burden of this debilitating disease for as many eligible patients as possible across the EU,” Van Hauwermeiren added.

How it works

Vyvgart works by blocking the activity of a protein called neonatal Fc receptor (FcRn). This protein receptor normally helps prevent antibodies circulating in the bloodstream from being destroyed. By inhibiting FcRn, Vyvgart is designed to lower the levels of MG-driving antibodies.

Vyvgart is the first therapy in its class to win approval for gMG in Europe, according to Argenx. The therapy has also been approved in the U.S. and Japan, and it is currently under review in China.

“We are proud to bring the first-and-only approved FcRn blocker to the EU on the heels of our U.S. and Japan launches, and remain steadfast in our mission to make Vyvgart available to patients across the globe,” Van Hauwermeiren said.

“We are thrilled to bring the first and only approved FcRn blocker to people living with generalized myasthenia gravis in the EU,” said Anant Murthy, PhD, Argenx’s EU general manager. “The current standard of care for these patients is insufficient for managing their symptoms and supporting their quality of life. We’re committed to collaborating with local health authorities across the region to establish access programs to reach as many eligible patients as possible.”

Vyvgart’s approval in the EU was supported by data from the Phase 3 ADAPT trial (NCT03669588), which assessed the safety and efficacy of Vyvgart (10 mg/kg) against a placebo in 167 adults with gMG. Participants were given four weekly infusions, followed by individualized treatment schedules based on response.

Results from the study showed that significantly more participants on Vyvgart than placebo experienced a meaningful reduction in symptom severity (68% vs. 30%) — defined as a two-point reduction on the MG Activities of Daily Living (MG-ADL) score that lasted at least four weeks. Another measure of disease severity, the Quantitative MG (QMG) scale, also favored Vyvgart over placebo.

Vyvgart was generally tolerated well in the ADAPT trial. The most common side effects were upper respiratory tract infections and urinary tract infections, each reported in approximately one out of 10 patients on Vyvgart.

“People living with gMG in the EU have long faced a significant unmet medical need due to limitations of commonly used therapies. The EC approval of Vyvgart adds an important new tool for clinicians providing care to these patients with a demonstrated efficacy and safety profile observed in clinical trials,” said Renato Mantegazza, MD, a professor in the department of neuroimmunology and neuromuscular diseases at Fondazione IRCCS Istituto Neurologico Carlo Besta in Italy.

“Living with gMG can severely impair a person’s ability to complete basic personal tasks,” said Mantegazza, who served as a trial investigator in ADAPT. “Now, patients and families living with the devastating impact of this disease have an effective treatment option that may help to significantly improve their quality of life.”