European panel recommends nipocalimab approval for gMG
European Medicines Agency committee advice follows U.S. FDA approval
A European Medicines Agency (EMA) committee recommended that the agency approve nipocalimab as an add-on treatment for generalized myasthenia gravis (gMG) patients aged 12 and older who have antibodies against acetylcholine receptor (AChR) or muscle-specific kinase (MuSK).
The Committee for Medicinal Products for Human Use (CHMP) recommendation comes a few months after nipocalimab was approved for the same indication in the U.S., where it is marketed as Imaavy.
The CHMP recommendation will be reviewed by the European Commission, which has final say over therapy approvals in Europe. The commission isn’t required to follow the CHMP’s recommendations, though it almost always does.
“Today’s positive CHMP opinion is a vital step forward in our unwavering commitment to improve the treatment landscape for people living with generalised myasthenia gravis across Europe,” Mark Graham, senior director and therapeutic area head for immunology at Johnson & Johnson Innovative Medicine EMEA, said in a company press release. “We look forward to the European Commission’s decision, which brings us closer to delivering an innovative treatment option to those who need it most.”
Recommendation based on encouraging trial data
MG is caused by antibodies that interfere with the communication between nerve and muscle cells, resulting in MG symptoms of muscle weakness and fatigue. Antibodies targeting AChR and MuSK are the most common ones driving the disease.
Nipocalimab, developed by Johnson & Johnson, is designed to reduce the levels of disease-driving antibodies by blocking the activity of the neonatal Fc receptor — a protein that normally stabilizes antibodies in the bloodstream and prevents their destruction, including the harmful ones driving MG. The therapy is given by infusion into the bloodstream.
The CHMP’s recommendation is based in large part on data from the Phase 3 VIVACITY-MG3 trial (NCT04951622), which tested add-on nipocalimab against a placebo in nearly 200 adults with gMG, most of whom were positive for MG-causing antibodies. Results showed that nipocalimab significantly outperformed the placebo in its ability to reduce disease severity and lower the levels of disease-driving antibodies.
“Results from the Phase 3 Vivacity-MG3 trial demonstrate nipocalimab has the potential to offer sustained disease control in a condition that is associated with fluctuations in symptoms,” Graham said.
The recommendation includes data from another study, Vibrance-MG (NCT05265273). That study is testing nipocalimab in adolescents with gMG, ages 12 to 17, and data have likewise indicated the therapy reduced disease severity and lowered antibody levels.
The therapy’s safety and tolerability profile was also consistent across trials. Common side effects of nipocalimab include respiratory tract infections, swelling in the extremities, and muscle spasms.
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