argenx’s VYVGART Achieves Ocular MG Efficacy and 87.5% CIDP Response Rate
argenx’s Phase 3 ADAPT OCULUS study showed VYVGART delivered significant ocular MG improvements (p=0.012 primary MGII; p=0.018 PRO+PE) at Week 4, supporting an sBLA submission. An ADHERE post-hoc analysis found 87.5% of treatment-naïve CIDP patients on VYVGART Hytrulo achieved clinical improvement in a median 39.5 days.
1. Phase 3 ADAPT OCULUS Demonstrates Ocular MG Efficacy
The Phase 3 ADAPT OCULUS trial enrolled patients with ocular myasthenia gravis, meeting its primary endpoint with a p=0.012 improvement in MGII patient-reported ocular scores at Week 4 versus placebo, and p=0.018 on the combined PRO+PE assessment. These results support a planned supplemental biologics license application submission to FDA to expand VYVGART’s label into ocular MG.
2. ADAPT SERON and Jr Data Extend gMG Evidence
The open-label extension of the Phase 3 ADAPT SERON trial showed rapid, sustained improvements in MG-ADL and QMG scores across MuSK-positive, LRP4-positive, and triple seronegative generalized MG patients, reinforcing VYVGART’s broad serostatus efficacy. ADAPT Jr results in adolescents (12-17 years) demonstrated minimal symptom expression in 72.7% of participants in cycle one and 80% in cycle two, with younger pediatric enrollment ongoing.
3. ADHERE Post-Hoc Analysis Supports CIDP Use
A post-hoc analysis of the ADHERE trial found that 87.5% of treatment-naïve CIDP patients receiving VYVGART Hytrulo achieved confirmed early clinical improvement with a median 39.5-day time to response. Real-world data from 225 patients indicated 85.7% of individuals switching from IVIg to VYVGART Hytrulo maintained or improved clinical stability without tolerability issues.
4. Neuromuscular Pipeline Advances with Phase 3 Trials
argenx outlined two Phase 3 CIDP studies: EMVIGORATE, comparing empasiprubart to IVIg, and EMNERGIZE, evaluating empasiprubart versus placebo. Follow-up results from a Phase 1b adimanebart study in congenital myasthenic syndromes demonstrated maintained QMG and six-minute walk test improvements through a 30-week follow-up.