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GSK Announces FDA Acceptance of New Meningococcal Jab BLA

GSK Announces FDA Acceptance of New Meningococcal Jab BLA

GSK plc GSK announced that the FDA has accepted its biologics license application (BLA) seeking approval of its 5-in-1 meningococcal ABCWY vaccine candidate, MenABCWY. The FDA has granted a standard review to the BLA and is expected to give its decision on Feb 14, 2025.

The MenABCWY vaccine candidate combines the antigenic components of GSK’s two popular licensed meningococcal vaccines, Bexsero (MenB) and Menveo (MenACWY). The MenABCWY combination targets the five serogroups of the bacteria Neisseria meningitides (A, B, C, W, and Y), which is primarily responsible for most invasive meningococcal disease cases globally.

Per GSK, a potential approval of this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and lead to a simplified immunization schedule. The 5-in-1 meningitis vaccine candidate has the potential to reduce the number of injections compared to current FDA-approved meningitis vaccines, as it has been designed to protect against all five vaccine-preventable serogroups with one combined product.

The BLA was based on data from a pivotal phase III study. The study met all its primary endpoints, including the non-inferiority of the vaccine candidate for all five Neisseria meningitides serogroups compared to Bexsero and Menveo in terms of an immune response.

GSK’s stock has risen 6.9% in the past year against a decline of 17.6% for the industry.

GSK boasts a broad vaccine portfolio that targets infectious diseases like meningitis, shingles, flu, polio and many more. GSK has more than 20 marketed vaccines in its portfolio. The company achieved strong vaccine growth of 25% at CER in 2023, driven by strong sales for its shingles vaccine, Shingrix and meningitis portfolio and exceptional contribution from the new respiratory syncytial virus (RSV) vaccine, Arexvy.

The company expects continued strong sales of Shingrix in 2024, primarily driven by outside U.S. markets. The vaccine is now approved in 39 countries. Arexvy sales are expected to be strong in 2024, driven by further penetration in the U.S. market as well as early adoption from international launches. Over time, GSK expects Arexvy to generate more than £3 billion in annual sales.

GSK is also focusing on accelerating the vaccines pipeline, particularly the expanded use of the RSV vaccine, pentavalent vaccine and MenABCWY to drive long-term growth. It has a leading suite of vaccine platform technologies, including next-generation mRNA, multiple antigens presenting systems, as well as adjuvant systems.

April 19, 2024

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