FDA grants priority review to nipocalimab for myasthenia gravis

The FDA has granted priority review to a Biologics License Application for nipocalimab to treat individuals with generalized myasthenia gravis who are antibody positive, according to the manufacturer.

In a press release, Johnson & Johnson said the FDA’s action was based on data from the phase 3 Vivacity-MG3 clinical trial, a randomized, double-blind, placebo-controlled, 24-week study that investigated safety and efficacy of the monoclonal antibody in 199 patients, 153 of whom were antibody positive (anti-AChR, anti-MuSK, anti-LRP4).

Participants were given either nipocalimab plus current standard of care (30 mg/kg IV loading dose followed by 15 mg/kg every 2 weeks) or placebo plus standard of care.

According to results cited in the release, treatment with nipocalimab led to a statistically significant improvement of mean change from baseline in the Myasthenia Gravis-Activities of Daily Living (MG-ADL) scale, with a greater reduction in MG-ADL (improvement of two or more points) compared with placebo and standard of care by weeks 22, 23 and 24.

The FDA grants priority review for novel therapies that are likely to provide significant improvement in safety and effectiveness of the treatment, diagnosis or prevention of serious conditions compared with existing therapeutic options.

The novel neonatal Fc receptor blocker was granted breakthrough therapy designation by the regulatory body in November to treat moderate to severe Sjögren’s disease.

“We welcome the FDA’s decision to grant priority review for the treatment of generalized myasthenia gravis, which underscores the need for additional treatment options in a broad population of people living with [generalized myasthenia gravis],” Katie Abouzahr, MD, of Johnson & Johnson Innovative Medicine, said in the release.