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.
argenx advances ARGX-119 to registrational study for congenital myasthenic syndromes
hVIVO supports Cidara Therapeutics' positive Phase 2b influenza study results
Sanofi's riliprubart receives orphan drug designation in Japan for CIDP
HUTCHMED gains China approval for ORPATHYS and TAGRISSO combination in lung cancer
Hikma Pharmaceuticals USA announces USD1bn of new US investment
UCB reports positive Phase 3 results for fenfluramine in CDKL5 deficiency disorder
WuXi AppTec's Nantong site receives 2025 Architizer A+Award
MGI partners with Negedia to enhance genomic sequencing in Italy
Speranza Therapeutics partners with Sunshine Labs for harm reduction solutions