Biopharmaceutical company GSK plc (LSE/NYSE: GSK) announced on Wednesday that the European Commission has approved a fully liquid version of Menveo, its meningococcal Group A, C, W-135, and Y conjugate vaccine (MenACWY).
This single-vial formulation, which eliminates the need for reconstitution, simplifies immunisation against invasive meningococcal disease (IMD) and is approved for individuals aged two years and older.
The approval follows two Phase IIb trials demonstrating comparable immunogenicity, tolerability and safety to the existing lyophilised/liquid version. This new presentation supports efficient vaccination workflows for a disease known for its severe, life-threatening complications. IMD remains a critical global health concern, with high mortality rates and significant long-term effects for survivors.
The original lyophilised Menveo formulation, approved in 2010, remains available. Menveo is authorised in over 60 countries and has delivered over 82 million doses globally, with more than 6 million distributed in Europe since 2017.
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