Argenx has secured the European Commission (EC) marketing authorisation for Vyvgart (efgartigimod alfa-fcab) to treat generalised myasthenia gravis (gMG) in adults.
The gMG is a rare and chronic autoimmune disease, occurs when immunoglobulin G (IgG) autoantibodies disrupt the signalling between nerves and muscles.
Vyvgart is a human IgG1 antibody therapy that works by binding to the neonatal Fc receptor (FcRn) in order to reduce the circulating IgG autoantibodies.
The European regulator indicated the drug as an add-on to standard therapy for the treatment of gMG in adults, who are anti-acetylcholine receptor (AChR) antibody positive.
The EC approval is applicable to all 27 Member states of the European Union (EU), along with Iceland, Norway and Liechtenstein.
Vyvgart is the first FcRn blocker approved in Europe to treat gMG in adults who are anti- AChR antibody positive, said the Dutch biotechnology company.
Argenx chief executive officer Tim Van Hauwermeiren said: “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.
“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.
“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.”
The EC approval of Vyvgart is based on results from the Phase 3 ADAPT trial, which evaluated the safety and efficacy of efgartigimod in 167 adults with gMG, in North America, Europe and Japan.
The study met its primary endpoint, with more anti-AChR antibody positive gMG patients being responders on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale compared with placebo.
People who had at least two-point reduction on the MG-ADL scale, for four or more consecutive weeks during the first treatment cycle, are considered as responders.
In the clinical trial, Vyvgart showed a safety profile, with upper respiratory tract infections and urinary tract infections as most common adverse reactions.
ADAPT trial investigator Renato Mantegazza said: “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.
“Living with gMG can severely impair a person’s ability to complete basic personal tasks. 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.”
Furthermore, Argenx is working together with commercial stage biopharmaceutical company Zai Lab, to commercialise Vyvgart in Canada and China, and additional regions.
