GSK’s Penmenvy Secures FDA Approval to Combat Five Major Meningococcal Serogroups Among Youth

GSK plc announced that the US Food and Drug Administration (FDA) approved Penmenvy, a vaccine for Meningococcal Groups A, B, C, W, and Y, for individuals aged 10 to 25 years. The vaccine protects against five major Neisseria meningitidis serogroups, which are common causes of invasive meningococcal disease (IMD). 

Approval Based on Positive Phase III Trial Results to Expand GSK’s Meningitis Vaccine Portfolio

The FDA’s approval was based on positive results from two Phase III clinical trials (NCT04502693; NCT04707391), which assessed the vaccine’s safety, tolerability, and immune response in more than 4,800 participants aged 10 to 25 years. Penmenvy combines antigenic components from GSK’s existing meningococcal vaccines, Bexsero (Meningococcal Group B Vaccine) and Menveo (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). With this approval, GSK expands its meningitis vaccine portfolio with a new immunization option. 

The phase 3 study evaluated the vaccine’s immunogenicity when administered in two doses six months apart. Researchers found that the immune response generated was comparable to a single dose of Menveo, a widely used meningococcal vaccine targeting serogroups A, C, W, and Y. Additionally, the vaccine demonstrated non-inferior efficacy against 110 MenB strains when compared to two doses of Bexsero, GSK’s existing MenB vaccine.  

MenB is the leading cause of IMD in adolescents and young adults, yet vaccination rates remain low. Fewer than 13% of individuals complete the recommended two-dose series, while only about 32% receive at least one dose. GSK currently supplies three out of every four MenB vaccine doses administered in the United States, positioning the company as a dominant player in this segment.

Tony Wood, Chief Scientific Officer at GSK, said, “We are excited about the opportunities ahead to help improve meningococcal vaccination coverage in the United States, especially for IMD caused by serogroup B. Building on our global leadership in meningococcal vaccination and our longstanding commitment to address unmet need in disease prevention, we aim to help protect more teens and young adults at a life stage when they are at an increased risk.”

IMD Affects 500,000 People Annually and Causes 50,000 Deaths with High Risk in Adolescents and Young Adults

IMD is a rare but severe disease that can be fatal in approximately 10–15% of cases within 24 hours of symptom onset, even with treatment. Early symptoms are often mistaken for the flu, making diagnosis challenging. Around 20% of survivors may face long-term effects, including brain damage, amputations, hearing loss, and nervous system disorders. Globally, IMD affects approximately 500,000 people annually and causes an estimated 50,000 deaths. While anyone can contract IMD, adolescents and young adults aged 16 to 23 are among those at highest risk. Behaviors such as living in close quarters, sharing drinks or utensils, and using communal smoking devices contribute to bacterial transmission. numbers

Judy Klein, President and Founder of Unity Consortium, a non-profit organization focused on adolescent health and immunization in the US, said, “The consequences of IMD can be devastating for those who contract it, for their families and friends. We welcome new tools to help protect more adolescents from meningococcal disease. Pentavalent MenABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.”

Currently, Penmenvy faces competition from several key players in the meningococcal vaccine market. Recently approved MenQuadfi by Sanofi, in response, offers alternative options to protect against meningococcal disease. MenQuadfi is designed to provide protection against four major serogroups, with a focus on reducing the number of doses required. Despite these competitors, GSK’s Penmenvy offers a significant advantage by combining five serogroups into a single vaccine, potentially streamlining vaccination schedules and improving coverage. 

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Denisse Sandoval