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.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval