Imaavy approved in EU to treat gMG patients 12 and older
J&J: Therapy is only FcRn blocker OK'd for use by adolescents
- Imaavy (nipocalimab) is now approved in the European Union to treat generalized myasthenia gravis in patients 12 and older.
- The therapy is indicated for individuals with self-reactive antibodies targeting the AChR or MuSK.
- Imaavy is the first FcRn blocker approved in the EU for adolescents with gMG.
Imaavy (nipocalimab) has been approved in the European Union as an add-on to standard of care treatment for adults and adolescents, ages 12 and older, with generalized myasthenia gravis (gMG) and self-reactive antibodies targeting the acetylcholine receptor (AChR) or muscle-specific kinase (MuSK).
The decision by the European Commission makes the Johnson & Johnson (J&J) therapy the first neonatal Fc receptor (FcRn) blocker approved in the EU for use by both pediatric and adult populations with either type of disease-causing self-reactive antibodies. The therapy was approved in the U.S. earlier this year for the same patient population. It’s also approved for gMG in Brazil and Japan.
“The approval of nipocalimab as the first FcRn blocker to treat a broad population of adults and adolescents living with gMG marks a meaningful advance in addressing persisting unmet needs and supporting more consistent, long-term disease management for patients,” Mark Graham, senior director and therapeutic area head immunology, Johnson & Johnson Innovative Medicine Europe, Middle East & Africa, said in a company press release announcing the approval.
“An estimated 56,000 to 123,000 people across Europe live with generalised myasthenia gravis … a condition that can make even simple activities like breathing or walking a daily challenge,” Graham said.
The medication’s approval was welcomed by researchers and patient groups, who noted Imaavy’s “sustained disease control and symptom relief” in clinical trials.
“This decision reflects a major advance in therapeutic approaches designed to enhance symptom control and the long-term management of gMG both in adolescents and adults,” said Andreas Meisel, MD, a neurologist and professor at Charité-University Medicine Berlin in Germany.
Myasthenia gravis, or MG for short, is marked by symptoms such as muscle weakness and fatigue. The conditon is caused by self-reactive antibodies that attack proteins involved in nerve-muscle communication. In most cases, these antibodies target AChRs, while a smaller proportion is marked by anti-MuSK antibodies.
The board of the European Myasthenia Gravis Association noted that MG “is an invisible disease, but its impact is anything but. It touches every part of our lives: our independence, education, careers, social life and mental health.”
More work is needed, the board noted.
“We need greater awareness, better resources, and stronger support systems so that people living with generalised myasthenia gravis can lead the lives they deserve,” the board said.
Imaavy tested in younger patients in Vibrance trial
Imaavy is an antibody-based therapy designed to block FcRn, a protein that normally prevents a type of circulating antibodies called IgG — including those causing MG — from being destroyed. By blocking FcRn, the treatment is expected to accelerate the rate of antibody elimination, thereby reducing their levels and easing disease severity.
Although other FcRn blockers are available to treat gMG, including Vyvgart and Vyvgart Hytrulo (efgartigimod formulations) and Rystiggo (rozanolixizumab), Imaavy is currently the only approved treatment for adolescents with the disease, J&J noted.
The therapy’s approvals for adults were supported by up to two years of data from the Phase 3 VIVACITY-MG3 clinical trial (NCT04951622), which launched in 2021. That trial showed that Imaavy, when added to standard care, was superior to a placebo at reducing disease severity in adults with gMG. Treatment also led to a sustained decrease in the levels of anti-AchR and anti-MuSK antibodies.
Data from the Phase 2/3 Vibrance-MG clinical trial (NCT05265273) supported the therapy’s approval for this younger patient group. Those results showed that Imaavy reduced the levels of self-reactive antibodies and disease severity in adolescents, ages 12-17, with gMG.
The therapy was generally safe and well tolerated across studies, the data showed.
With strong data from the Vivacity-MG3 and Vibrance-MG studies, [Imaavy] provides an important new option that could help achieve sustained disease control and support greater stability for patients managing this challenging condition.
Francesco Saccà, a practicing neurologist and professor at the University Federico II of Naples in Italy, noted that “even with advances in treatment, people living with generalised myasthenia gravis continue to experience unpredictable symptom fluctuations that can disrupt daily life.”
The trials testing Imaavy have proven positive, Saccà said.
“With strong data from the Vivacity-MG3 and Vibrance-MG studies, [Imaavy] provides an important new option that could help achieve sustained disease control and support greater stability for patients managing this challenging condition,” Saccà said.
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