Efgartigimod alfa

Specification

• Cat#: THA-0129
• Product Name: Efgartigimod alfa
• Description: Efgartigimod alfa is a neonatal Fc receptor blocker used to treat generalized myasthenia gravis in patients who are AChR-antibody positive and chronic inflammatory demyelinating polyneuropathy.
• Sequences: SUBUNIT_1: DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALKFHYTQKSLSLSPGK SUBUNIT_2: DKTHTCPPCPAPELLGGPSVFLFPPKPKDTLYITREPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALKFHYTQKSLSLSPGK
• Molecular Weight: 54000.0 Da
• Introduction: Myasthenia gravis (MG) is an autoimmune disorder characterized by significant muscle weakness-particularly in the eye, throat, and extremities-caused by autoantibodies attacking the neuromuscular junction. The production of IgG autoantibodies against acetylcholine receptors (AChRs) is one of the more common pathophysiological mechanisms behind MG, and results in the destruction of these receptors and a reduction in electrical nerve impulses. Efgartigimod alfa is a first-in-class antagonist of the neonatal Fc receptor (FcRn) used in the treatment of MG. IgG antibodies, including the autoantibodies responsible for MG symptoms, can be 'recycled', a process that significantly extends their half-life by evading lysosomal degradation via binding with FcRn. By antagonizing this interaction, efgartigimod alfa prevents this recycling phase and thus decreases the half-life of IgG, effectively lowering circulating levels of IgG autoantibodies against AChRs. Efgartigimod alfa for intravenous use was granted FDA approval on December 17, 2021 and European Commission approval on August 11, 2022. A formulation for subcutaneous use that combines efgartigimod alfa and hyaluronidase was first approved by the FDA in June 2023.
• Purity: >99% by SDS-Page and HPLC analysis
• Formula: Not Available
• Appearance: Liquid

Pharmaceutical Information

• Pharmacodynamics: Efgartigimod alfa exerts its pharmacologic effect by reducing circulating levels of the autoantibody responsible for myasthenia gravis symptoms. It is administered as a once-weekly intravenous or subcutaneous infusion, given for 4 weeks per treatment cycle, with the option to initiate additional treatment cycles as clinically indicated after at least 50 days have passed following the previous cycle. Because efgartigimod alfa reduces circulating IgG levels, patients undergoing therapy may be at greater risk of infection due to a depressed immune response. It should not be initiated in patients with an active infection, and consideration should be given to holding therapy in patients who develop a serious infection during a treatment cycle.
• Targets: IgG receptor FcRn large subunit p51