China Approves Efgartigimod Injection for Generalized Myasthenia Gravis

On July 16, 2024, China ZaiLab announced that the National Medical Products Administration (NMPA) has granted marketing authorization for its new biological product, known as Wale®. This medication is available as a subcutaneous injection, each vial containing 1000 mg of Igatimod in a 5.6 ml solution. It is intended to be used as an adjunct therapy alongside conventional treatments for adult patients with generalized myasthenia gravis (gMG) who test positive for acetylcholine receptor (AChR) antibodies.

Igatimod represents a significant advancement in the realm of FcRn inhibitors globally. This innovative medication is designed to combat autoimmune diseases that are mediated by antibodies. In January 2021, ZaiLab acquired the rights to develop and commercialize Igatimod in Greater China from Argenx, a company known for its innovative therapies. By July 2023, the NMPA had already approved the intravenous form of Igatimod, laying a solid foundation for the subsequent approval of its subcutaneous form.

The approval of the subcutaneous injection form of Igatimod is supported by the positive results from the ADAPT-SC clinical trials conducted globally. The study demonstrated that subcutaneous administration of Igatimod not only replicates the effectiveness of the intravenous form but also offers superior safety. This development provides a broader range of treatment options for adults with gMG, enhancing their flexibility in managing the disease.

The availability of more treatment options is expected to significantly improve the quality of life for patients by enhancing the effectiveness of disease management. This progress stands to greatly benefit those suffering from gMG, offering them better control over their condition and potentially leading to substantial improvements in their daily lives.