Shots:
- The EC has approved Vyvgart (efgartigimod alfa) 1000mg for SC injection as a monotx. for adults with progressive or relapsing active chronic inflammatory demyelinating polyneuropathy (CIDP) after prior corticosteroid or immunoglobulin treatment in all 30 EEA states
- The EC approval was based on the ADHERE trial, showing 66.5% (214/322) of VYVGART SC-treated pts showed clinical improvement, with benefits seen across all subtypes. The study met its 1EP with a 61% reduction in relapse risk vs PBO. 99% of participants joined the open-label extension, and safety was consistent with prior data
- Efgartigimod SC is an IgG1 antibody fragment that reduces harmful IgG antibodies by blocking their recycling via the neonatal Fc receptor (FcRn)
Ref: Globenewswire| Image: Argenx | Press Release
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