▎WuXiEdited by Kant Content Team

GSK recentlyAnnounced that the US FDA has approvedIts combination vaccine Penmenvy (MenABCWY) has been launched for use in the 10-25 age group. This vaccine targets the five most common serogroups of meningococcal bacteria, which are typically responsible for causingCauses of Invasive Meningococcal Disease (IMD)。Previously, this therapy was selected by the industryWell-known institutions in ChinaClarivatePublishedDrugs to WatchThe report is considered to have the potential to become a blockbuster new drug within five years.

Invasive meningococcal disease is a rare but serious illness,Is the main cause of meningitis and sepsis,Can lead to life-threatening complications and even death.One in ten people infected with meningococcal disease will die, sometimes within 24 hours of receiving treatment.One in seven survivors will suffer long-term consequences such as brain damage, amputation, hearing loss, and neurological problems.Five serogroups of meningococcal bacteria (A, B, C, W, and Y) cause nearly all cases of invasive meningococcal disease worldwide.

MenABCWY is a "five-in-one" vaccine developed by GSK, whose active ingredients combine the antigen components of the approved meningococcal vaccines Bexsero and Menveo, providing protection against the aforementioned five meningococcal serogroups for vaccinated individuals.MenABCWY combines two effective vaccines into one, aiming to reduce the number of injections, simplify the immunization schedule, and thereby increase vaccine coverage, helping to reduce the overall burden of disease.

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MenABCWY's approval was supported by the results of two Phase 3 clinical trials, which evaluated the vaccine's safety, tolerability, and immune response in more than 4,800 participants aged 10 to 25. Previously released trial results showed，MenABCWY vaccine successfully met all primary endpoints,Including being non-inferior to one dose of GSK's A, C, Y, and W meningococcal vaccine in terms of immunogenicity, as well as being non-inferior to two doses of GSK's B meningococcal vaccine in the immune response generated against 110 different invasive strains of B meningococcal bacteria.In addition, the vaccine showed good tolerability, and its safety profile was consistent with the aforementioned two vaccines.

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References:

[1] PENMENVY, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. Retrieved February 14, 2025, from https://us.gsk.com/en-us/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/

[2] GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains. Retrieved May 12, 2023 from https://www.gsk.com/en-gb/media/press-releases/gsk-presents-pivotal-data-at-espid/

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