GSK's Five-in-One Meningococcal Vaccine Penmenvy Receives FDA Approval for Ages 10–25

GSK recently announced that the U.S. FDA has approved itsCombination Vaccine Penmenvy (MenABCWY)Launched, for use in the 10-25 age group. This vaccineThe five most common serogroups of meningococcal bacteria (A, B, C, W, and Y) are typically responsible for causing invasive meningococcal disease (IMD).Previously, this therapy was selected for inclusion in the Drugs to Watch report released by the well-known industry institution Clarivate.Considered to have the potential to become a blockbuster drug within five years.

▍Excellent Clinical Trial Results for MenABCWY

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 non-inferiority in immunogenicity compared to one dose of GSK's meningococcal serogroups A, C, Y, and W vaccine.And it is non-inferior to two doses of GSK's Group B meningococcal vaccine in terms of the immune response generated against 110 different invasive strains of Group B meningococcal bacteria.In addition, the vaccine showed good tolerability, and its safety was consistent with the two vaccines mentioned above.

▍Current Status of Approved Vaccines for Invasive Meningococcal Disease

Invasive meningococcal disease is a rare but serious illness and a leading cause of meningitis and septicemia, which can lead to life-threatening complications and even death. Among those who contract meningococcal disease, one in ten will die, sometimes within as little as 24 hours after treatment begins. One in seven survivors will suffer long-term consequences such as brain damage, limb amputation, hearing loss, and neurological problems. Five meningococcal serogroups (A, B, C, W, and Y) account for nearly all cases of invasive meningococcal disease across most regions of the world.

As of now, in addition to the newly approved combination vaccine Penmenvy (MenABCWY)Globally, 5 MPCV-ACYW products from 4 manufacturers have been approved for marketing:

• In 2005, Sanofi Pasteur successfully developed the first DT-based MenACYW vaccine (Menactra), which can be administered starting at 9 months of age;

• In 2010, the Men-ACYW-CRM197 vaccine (Menveo) developed by Novartis using CRM197 as a carrier was approved for administration starting at 2 months of age. In 2015, this vaccine was acquired by GSK.

• In 2012, the MPCV-ACYW vaccine (Nimenrix) developed by GSK with TT as a carrier could be administered starting at 6 weeks of age. In 2015, Pfizer exchanged this vaccine with GSK.

• In 2020, the MenACYW-TT vaccine (MenQudafi) developed by Sanofi Pasteur with TT as a carrier was launched, suitable for individuals over 2 years old.

• At the end of 2021, CanSino's MenACYW-CRM197 (Menhycia), which uses CRM197 as a carrier, was approved for marketing in China and can be administered starting at 3 months of age.

• In 2023, Pfizer's pentavalent vaccine MenABCYW (Penbraya™), using TT as the carrier protein, was approved, becoming the first pentavalent meningococcal vaccine targeting adolescents and young adults aged 10-25.

Source:

WuXi AppTec "FDA Approves GSK's Potential Blockbuster Vaccine!"

Vaccine Hub: "A Comprehensive Overview! Global Research Progress on Meningococcal Polysaccharide Conjugate Vaccines"