Now Approved
For patients 12 years of age and older living with anti-AChR or anti-MuSK antibody-positive generalized myasthenia gravis (gMG)
Disease control that lasts and lasts and lasts1,2
For patients 12 years of age and older living with anti-AChR or anti-MuSK antibody-positive generalized myasthenia gravis (gMG)
Disease control that lasts and lasts and lasts1,2
as demonstrated by an improvement in MG-ADL over a 24-week clinical trial
Significant improvement in daily function1,2
4.7-point
4.7-point
mean reduction in MG-ADL total score to 24 weeks (3.3 for placebo, P=0.002)1,2*
Why IMAAVY?
The first and only fully human FcRn-blocking mAb designed for long-lasting, targeted binding.1,3–5
IMAAVY demonstrated IgG reduction over 24 weeks.
IMAAVY + SOC: superior disease control that didn’t fade1,2
IMAAVY + SOC was proven superior to placebo + SOC as measured by mean change in activities of daily living (MG-ADL) and muscle weakness (QMG) total score from baseline over 24 weeks.
IMAAVY was evaluated out to an additional 60 weeks in an ongoing OLE study6
Efficacy and safety results were consistent with those seen in the double-blind phase.
45% (40/89) of patients receiving steroids at baseline were able to decrease or discontinue steroid use.
A proven safety profile over 24 weeks1,2
The most common adverse reactions (≥10%) in patients with gMG treated with IMAAVY were respiratory tract infections, peripheral edema, and muscle spasms.
In the pivotal study, the safety of IMAAVY + SOC was evaluated vs placebo + SOC.
AChR=acetylcholine receptor; FcRn=neonatal fragment crystallizable receptor; IgG=immunoglobulin G; mAb=monoclonal antibody; MG-ADL=Myasthenia Gravis Activities of Daily Living; MOA=mechanism of action; MuSK=muscle-specific tyrosine kinase; OLE=open-label extension; SOC=standard of care.
