Question 1

Who is IMAAVY indicated for?

Accepted Answer

IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Question 2

Can patients take IMAAVY while pregnant?

Accepted Answer

There are limited data on the use of IMAAVY in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. There is a pregnancy safety study for IMAAVY. If IMAAVY is administered during pregnancy, or if a patient becomes pregnant while receiving IMAAVY, healthcare providers should report IMAAVY exposure by contacting Janssen at 1-800-526-7736 or www.IMAAVY.com

Question 3

How is IMAAVY administered?

Accepted Answer

IMAAVY is administered as an intravenous infusion lasting at least 15 minutes every 2 weeks (following an initial starting dose administered over at least 30 minutes). Please see Dosing and Administration Guide for more details.

Question 4

What are the side effects of IMAAVY?

Accepted Answer

The most common adverse reactions (≥10% of patients) for patients taking IMAAVY were respiratory tract infections (18%), peripheral edema (12%), and muscle spasms (12%). Rates of serious adverse events in both arms were similar (9% for IMAAVY, 14% for placebo). Please read the Important Safety Information located at the bottom of the screen and the Medication Guide to learn more about these and other risks for IMAAVY.

Question 5

What is the mechanism of action of IMAAVY?

Accepted Answer

IMAAVY is a human IgG1 monoclonal antibody that binds to neonatal Fc receptor (FcRn), resulting in the reduction of circulating IgG levels.

Question 6

What makes a fully human FcRn blocker different?

Accepted Answer

A fully human design may help to minimize immune reactions by resembling natural human proteins. It has a lower risk of eliciting neutralizing antidrug antibodies vs a nonhuman mAb.

Question 7

How much did IMAAVY reduce IgG in the clinical study? Was this the same for all serotypes?

Accepted Answer

In the phase 3 pivotal study, the pharmacological effect of IMAAVY was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels. In patients positive for anti-AChR and anti-MuSK autoantibodies who were treated with IMAAVY, there was a reduction in anti-AChR and anti-MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern.

Question 8

Does IMAAVY impact IgG production?

Accepted Answer

IMAAVY does not impact IgG production; it reduces circulating IgG by binding FcRn and preventing IgG recycling. In the phase 3 pivotal study, the pharmacological effect of IMAAVY was assessed by measuring the decrease in serum IgG levels and anti-AChR and anti-MuSK autoantibody levels. In patients positive for anti-AChR and anti-MuSK autoantibodies who were treated with IMAAVY, there was a reduction in anti-AChR and anti-MuSK autoantibodies relative to baseline. Decreases in total IgG levels followed a similar pattern. IMAAVY binds to FcRn with high specificity and high affinity at both neutral (extracellular) and acidic (intracellular) pH levels, resulting in the reduction of circulating IgG levels, including those of pathogenic IgG.

Question 9

Does IMAAVY impact immunoglobulins other than IgG?

Accepted Answer

IMAAVY demonstrated a reduction only in immunoglobulin G (IgG).

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