GSK announces that the US FDA has accepted for review a Biologics License Application (BLA) for its 5-in-1 meningococcal ABCWY vaccine candidate (MenABCWY).
The Prescription Drug User Fee Act (PDUFA) action date for a U.S. FDA regulatory decision on this application is February 14, 2025.
This submission is based on results from the pivotal Phase III trial showing that all primary endpoints were met.
The vaccine candidate offers broad coverage against the five most common bacterial groups causing invasive meningococcal disease, and could reduce the number of injections to simplify vaccination, if approved.
' The combination of protection offered by these vaccines in fewer injections aims to reduce the number of injections, simplifying vaccination. This may help increase series completion and vaccination coverage, and reduce the overall burden of IMD, as unvaccinated adolescents are particularly at risk of infection and potential epidemics' says the group.
Copyright (c) 2024 CercleFinance.com. All rights reserved.
GSK plc is a global biopharma company. The Companyâs segments include Commercial Operations and Research and Development. It develops cancer medicines for patients, including ovarian cancer, endometrial cancer, and multiple myeloma. It has developed monoclonal antibodies to help treat different diseases. Its product areas include vaccines, specialty medicines, and general medicine. It is also focused on addressing the unmet treatment needs of patients with respiratory and inflammatory conditions. Its vaccine portfolio includes more than 20 vaccines that help to protect people from a range of diseases and infections, including meningitis, shingles and flu, among others. Its specialty medicines include medicines for immune-mediated conditions. Its specialty medicines are also engaged in developing medicines for respiratory disease and HIV. Its general medicines include inhaled medicines for asthma and chronic obstructive pulmonary disease, antibiotics, and medicines for skin diseases.