TAKE CHARGE
of gMG
ZILBRYSQ is the first and only FDA-approved self-administered complement C5 inhibitor approved for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive (Ab+).1,2
Explore the data
RAPID
Demonstrated statistically significant improvement vs placebo in MG-ADL total score (-4.39 vs -2.30; P<0.001) at Week 12 in the pivotal trial1,2*
*The safety and efficacy of ZILBRYSQ were evaluated in RAISE, a phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled study (N=174).2
SUSTAINED
Efficacy maintained for over 2 years (open-label extension study Week 108) was consistent with the primary endpoint of the pivotal trial2,3†‡
The ZILBRYSQ open-label extension study was designed to evaluate safety and was not placebo controlled; therefore, efficacy or clinical significance should be interpreted with caution.
In the RAISE-XT open-label extension, change from baseline in MG-ADL score was -7.14 for ZILBRYSQ (SE: 0.44; n=183) at Week E108. RAISE-XT is an ongoing, multicenter, open-label extension study of ZILBRYSQ in adult study participants with anti-AChR Ab+ gMG who completed the Phase 2 or 3 (RAISE) study (N=200). The primary endpoint evaluated the long-term safety and tolerability of ZILBRYSQ.3
EMPOWERED
A once daily self-administered injection allows patients to take an active role in their treatment1§
The recommended dosage of ZILBRYSQ is given once daily as a subcutaneous injection via a prefilled syringe.1
ZILBRYSQ is the first and only FDA-approved self-administered complement C5 inhibitor approved for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive (Ab+).1,2
TAKE CHARGE
of gMG
Explore
the data
RAPID
Demonstrated statistically significant improvement vs placebo in MG-ADL total score (-4.39 vs -2.30; P<0.001) at Week 12 in the pivotal trial1,2*
*The safety and efficacy of ZILBRYSQ were evaluated in RAISE, a Phase 3, 12-week, multicenter, randomized, double-blind, placebo-controlled study (N=174).2
SUSTAINED
Efficacy maintained for over 2 years (open-label extension study Week 108) was consistent with the primary endpoint of the pivotal trial2,3†‡
The ZILBRYSQ open-label extension study was designed to evaluate safety and was not placebo controlled; therefore, efficacy or clinical significance should be interpreted with caution.
In the RAISE-XT open-label extension, change from baseline in MG-ADL score was -7.14 for ZILBRYSQ (SE: 0.44; n=183) at Week E108. RAISE-XT is an ongoing, multicenter, open-label extension study of ZILBRYSQ in adult study participants with anti-AChR Ab+ gMG who completed the Phase 2 or 3 (RAISE) study (N=200). The primary endpoint evaluated the long-term safety and tolerability of ZILBRYSQ.3
EMPOWERED
A once daily self-administered injection allows patients to take an active role in their treatment1§
The recommended dosage of ZILBRYSQ is given once daily as a subcutaneous injection via a prefilled syringe.1
Actor portrayal.
Rapid and statistically significant improvement
vs placebo in MG-ADL total score at Week 12 in the RAISE trial1,2‡
Sustained efficacy
across multiple gMG outcome measures in the RAISE-XT trial4§
Self-administered at home or away
with a ready-to-use subcutaneous injection1
In the pivotal RAISE clinical trial, change from baseline in MG-ADL score was -4.39 for ZILBRYSQ (95% CI: -5.28, -3.50; n=86) vs -2.30 for placebo (95% CI: -3.17, -1.43; P<0.001; n=88). The safety and efficacy of ZILBRYSQ were evaluated in a 12-week, Phase 3, multicenter, randomized, double-blind, placebo-controlled study (N=174).1,2
In the RAISE-XT open-label extension, change from baseline in MG-ADL score was -7.14 for ZILBRYSQ (SE: 0.44; n=183) at Week E108. RAISE-XT is an ongoing, multicenter, open-label extension of ZILBRYSQ in adult study participants with anti-AChR Ab+ gMG who completed the Phase 2 or 3 (RAISE) study (N=200). The primary endpoint evaluated the long-term safety and tolerability of ZILBRYSQ.3
C5=complement component 5; CI=confidence interval; MG-ADL=Myasthenia Gravis Activities of Daily Living; SE=standard error.
References:
- ZILBRYSQ [Prescribing Information]. Smyrna, GA: UCB, Inc.
- Howard JF Jr, Bresch S, Genge A, et al; RAISE Study Team. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, Phase 3 study. Lancet Neurol. 2023;22(5):395-406. doi:10.1016/S1474-4422(23)00080-7
- Howard JF Jr, Freimer M, Genge A, et al; on behalf of the RAISE-XT Study Team. Long-term safety and efficacy of zilucoplan in generalized myasthenia gravis: 120-week interim analysis of RAISE-XT. Poster presented at: American Association of Neuromuscular & Electrodiagnostic Medicine Annual Meeting & Myasthenia Gravis Foundation of America Scientific Session; October 15-18, 2024; Savannah, GA. Poster 192.
- Howard JF Jr, Freimer M, Genge A, et al. Response rates with zilucoplan in generalised myasthenia gravis: 120-week interim analysis of RAISE-XT. Presented at: International Congress on Neuromuscular Diseases; October 25-29, 2024; Perth, Australia. Session OS.03.06.
