FcRn antagonist efgartigimod enters review in the European Union Zai Lab introduced into China

Zai Lab partner argenx recently announced that the European Medicines Agency (EMA) has accepted a marketing authorization application (MAA) for efgartigimod, an FcRn antagonist for the treatment of systemic myasthenia gravis (gMG)

Myasthenia gravis (MG) is a neuromuscular disease that is mediated by pathogenic IgG and seriously affects the quality of life.

If approved, efgartigimod will become the first and only FcRn antagonist to receive regulatory approval and will bring a first-of-its-kind targeted therapy to gMG patients

The regulatory application of efgartigimod for the treatment of gMG is based on the results of the pivotal Phase 3 ADAPT trial

The results showed that the ADAPT trial reached the primary endpoint: in patients with acetylcholine receptor antibody positive (AChR Ab+) gMG, according to myasthenia gravis activity of daily living (MG-ADL) score, compared with the placebo group, the efgartigimod treatment group had more A high proportion of patients are responders (67.

After completing the ADAPT trial, 90% of patients entered the ADAPT plus trial, an open-label extension study that lasted 3 years to evaluate the long-term safety and tolerability of efgartigmod

efgartigimod mechanism of action

Efgartigimod is an antibody fragment under development, designed to reduce pathogenic immunoglobulin G (IgG) antibodies and block IgG circulation

On January 6, 2021, Zai Lab and argenx announced that the two parties have reached an exclusive authorized cooperation.

According to the terms of the agreement, Zai Lab will obtain the exclusive right to develop and commercialize efgartigimod in Greater China

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Original source: argenx Announces Validation of European Marketing Authorization Application for Efgartigimod in Generalized Myasthenia Gravis