Efgartigimod (Vyvgart) (AChR-positive gMG) Expand Company: Argenx Clinical trial(s): ADAPT (Stage 3 complete) More information NICE status: In negotiations with NICE after 3rd appraisal committee meeting MHRA status: Approved Learn more about Efgartigimod.
Zilucoplan (Zilbrysq) (AChR-positive gMG) Expand Company: UCB Clinical trial(s): RAISE (Stage 3 complete) More information NICE status: Initial negative guidance after first committee meeting, second committee meeting pending MHRA status: Approved Learn more about Zilucoplan.
Rozanolixizumab (Rystiggo) (AChR-positive and MuSKR-positive gMG) Expand Company: UCB Clinical trial(s): MycarinG (Stage 3 complete) More Information NICE status: First committee meeting 14/8/24 MHRA status: Approved Learn more about rozanolixizumab.
Nipocalimab (AChR-positive gMG) Expand Company: Janssen Clinical trial(s): Vivacity (Stage 2 complete) More information NICE status: Awaiting development (topic selected 3/1/24) MHRA status: Approved Nipocalimab is a FcRn inhibitor, similar to how efgartigimod and rozanolixizumab work. It has already shown clinical effectiveness in treating four other autoantibody-driven diseases, such as rheumatoid arthritis.
Pozelimab & Cendisiran (AChR-positive gMG and LRP4R-positive gMG) Expand Company: Regeneron Clinical trial(s): NIMBLE (estimated to complete 23/3/28) link to trial Recruiting in UK sites: Birmingham and Sheffield NICE status: No appraisal status at present time MHRA status: Not approved at present time · Pozelimab and Cendisiran are both complement inhibitors and work similarly to zilucoplan, eculizumab, and ravulizumab. There are being used as a combinatorial therapy to treat myasthenia gravis.
B Cell Inhibitors Expand Inebilizumab (AChR-positive gMG or MuSKR-positive gMG) · Company: Amgen · Trial: MINT (Phase 3, estimated completion 29/11/27, no UK trial sites) Mezagitamab (AChR-positive gMG or MuSKR-positive gMG) · Company: Takeda · Trial: Phase 2, completed 12/7/22 Satralizumab (AChR-positive gMG or MuSKR-positive gMG or LRP4R-positive gMG) · Company: Roche · Trial: LUMINESCE (Phase 3, estimated completion 2/9/24, no UK trial sites) Telitacicept (AChR-positive gMG or MuSKR-positive gMG) · Company: RemeGen Co · Trial: RemeMG (Phase 3, estimated completion 7/2027, not yet recruiting)
T Cell Therapy (Myasthenia gravis) Expand Descartes-08 · Company: Cartesian Therapeutics · Trial: Phase 2b (estimated completion 31/3/26, no UK trial sites)
ARGX-119 (Congenital Myasthenic Syndromes) Expand Company: Argenx Clinical trial(s): Phase 1 (estimated completion 2/8/24, no UK trial sites)