Penmenvy FDA Approval History
Last updated by Judith Stewart, BPharm on Feb 17, 2025.
FDA Approved: Yes (First approved February 14, 2025)
Brand name: Penmenvy
Generic name: meningococcal groups A, B, C, W, and Y vaccine
Dosage form: Lyophilized Powder for Injection
Company: GlaxoSmithKline
Treatment for: Meningococcal Disease Prophylaxis
Penmenvy (meningococcal groups A, B, C, W, and Y vaccine) is a vaccine indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals 10 through 25 years of age.
- Penmenvy combines the antigenic components of GSK’s two well-established meningococcal vaccines: Bexsero (MenB vaccine) and Menveo (MenACWY vaccine). Penmenvy is a pentavalent MenABCWY vaccine that provides broad serogroup coverage in one vaccine, reducing the total number of injections required for protection against invasive meningococcal disease.
- Invasive Meningococcal Disease (IMD) is an uncommon but serious illness that can lead to death for up to one in six of those who contract it in as little as 24 hours from onset, despite treatment. Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems. Adolescents and young adults between the ages of 16 and 23 years are at high risk due to common behaviors that help transmit the bacteria that cause IMD such as living in close quarters like college dormitories.
- Penmenvy protects against invasive meningococcal disease by complement-mediated antibody-dependent killing of Neisseria meningitidis serogroups A, B, C, W, and Y.
- FDA approval of Penmenvy was supported by positive results from two phase III trials (NCT04502693 and NCT04707391) which evaluated the vaccine’s safety, tolerability, and immune response in over 4,800 participants aged 10-25 years.
- Bexsero was first approved in 2015 for the prevention of IMD caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years.
- Menveo was first approved in 2010 for the prevention of IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in individuals aged from 2 months through 55 years of age. - Penmenvy is administered by intramuscular injection as two doses, spaced 6 months apart.
- Warnings and precautions associated with Penmenvy include syncope (fainting).
- Commonly reported (≥10%) solicited adverse reactions after Dose 1 and Dose 2, respectively in individuals aged 10 through 25 years include pain at the injection site (92% and 88%), fatigue (51% and 42%), headache (42% and 36%), myalgia (15% and 12%), nausea (15% and 10%), erythema (13% and 12%), and swelling (13% and 12%).
Commonly reported (≥10%) solicited adverse reactions after Dose 1 and Dose 2, respectively in MenACWY conjugate vaccine-experienced individuals aged 15 through 25 years include pain at the injection site (80% and 74%), headache (41% and 33%), fatigue (40% and 33%), myalgia (15% and 13%), and nausea (15% and 12%).
Development timeline for Penmenvy
Further information
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