Healthcare products company Johnson & Johnson (J&J) (NYSE:JNJ) announced on Thursday that the US Food and Drug Administration (FDA) has granted Priority Review to the nipocalimab Biologics License Application (BLA) for the treatment of antibody-positive generalised myasthenia gravis (gMG).

This decision is supported by positive results from the Phase 3 Vivacity-MG3 study, which demonstrated significant improvement in disease control with nipocalimab plus standard of care compared with placebo plus standard of care.

gMG is a rare autoimmune disease affecting approximately 700,000 people globally. Priority Review typically results in a shorter FDA review period, aiming to expedite the availability of potentially life-changing therapies.

J&J has also submitted a Marketing Authorisation Application for nipocalimab in gMG to the European Medicines Agency and received Breakthrough Therapy Designation from the FDA for the treatment of Sjögren's disease.