Efgartigimod Subcutaneous Injection Approved in China for the Treatment of Generalized Myasthenia Gravis
Drug Approval
On July 16, 2024, the news of China ZaiLab announced that the national drug supervision and administration (NMPA) has approved the new biological products and wale ®'s application for marketing authorisation. This product is a kind of subcutaneous injection dosage forms, a bottle containing Edgar moder 1000 mg (5.6 ml), it will serve as a complementary therapy, combined with conventional treatment drugs, to treat the acetylcholine receptor (AChR) antibody testing positive for adult body in patients with myasthenia gravis (gMG) group.
Igatimod, as a novel therapeutic drug, marks a major breakthrough in the field of FcRn inhibitorsFcRn inhibitors worldwide. The drug is designed to fight the autoimmune diseases mediated by antibodies. In January 2021, introduced ZaiLab Argenx from companies in this innovative drugs, and get the greater China region in China to Edgar moder exclusive development and commercial rights and interests. By July 2023, the NMPA had approved early Edgar moder intravenous injection of biological products listed licensing applications, application laid a solid foundation for the subsequent treatment.
The approved Edgar moder subcutaneous injection dosage forms, behind it is relying on the worldwide to 3) ADAPT - SC positive results of clinical trials. The study showed that by subcutaneous injection of Edgar maud, not only can copy a comparable to those of intravenous curative effect, and excels in safety.
With the approval of the subcutaneous form of igammod, there are now more treatment options available for those with gMG in adults, which undoubtedly increases their flexibility in disease management. This progress is also expected to greatly promote the effect of disease treatment for patients, bringing significant improvements in their lives.
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