REG - GSK PLC - Menveo new single-vial approved by US FDA

GSKAnnouncement

17/10/2022 07:00

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RNS Number : 0177D  GSK PLC  17 October 2022

Issued: 17 October 2022, London UK

 

US FDA approves Menveo in a new single-vial presentation to help prevent
disease caused by meningococcal bacteria serogroups A, C, Y, and W

 

·   Single-vial presentation option removes the need for reconstitution of
Menveo before use in individuals 10 through 55 years of age.

 

 

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has approved a new presentation of Menveo [Meningococcal
(Groups A, C, Y, and W-135) Oligosaccharide Diptheria CRM197 Conjugate
Vaccine] for individuals aged 10 to 55 years to help prevent invasive
meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and
W. The Menveo one-vial presentation now comes in a ready to use single vial
giving healthcare providers a more convenient option. The Menveo one-vial
presentation will initially be available to US federal customers, with broader
availability anticipated in mid-2023.

 

Invasive meningococcal disease (IMD), known as meningitis, is an uncommon but
serious illness that can cause life-threatening complications or even death.1
IMD is caused by Neisseria meningitidis, with the majority of cases caused by
serogroups (A, B, C, W, Y) in most of the world.1 Among those who contract
meningitis, one in ten will die, despite treatment, sometimes in as little as
24 hours.1 One in five (up to 20%) of meningitis survivors suffer long-term
consequences, such as brain damage, amputations, hearing loss and nervous
system problems.1

 

Roger Connor, President, Vaccines and Global Health, GSK, said: "Outbreaks of
this dangerous disease continue to occur, impacting families, health systems
and society. This FDA approval of Menveo one-vial presentation offers greater
convenience to healthcare providers to help prevent this disease in at-risk
populations in the United States."

 

The original two-vial presentation of Menveo requiring reconstitution, was
approved by the FDA in 2010 and remains available for use in individuals from
two months to 55 years of age.

 

About Menveo

The Menveo vaccine (supplied in a two-vial presentation) for meningococcal
groups A, C, Y, and W has been approved in over 60 countries, with more than
72 million doses distributed worldwide since 2010. It offers extensive
evidence of immunogenicity and a well-characterised safety profile. Menveo
does not prevent Neisseria meningitidis serogroup B infections.

 

The US Prescribing Information is available here
(https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF)
.

 

Important Safety Information for Menveo in the US

 

The following is based on the US Prescribing Information for Menveo. Please
consult the full Prescribing Information for all the labeled safety
information.

 

 •    Do not administer Menveo to individuals with a severe allergic reaction (e.g.,
      anaphylaxis) to a previous dose of Menveo, to any component of this vaccine,
      or to any other diphtheria toxoid-containing vaccine.
 •    Appropriate medical treatment must be available should an acute allergic
      reaction, including an anaphylactic reaction, occur following administration
      of Menveo.
 •    Syncope (fainting) has occurred in association with administration of Menveo.
      Procedures should be in place to avoid injury from fainting.
 •    Some individuals with altered immunocompetence, including some individuals
      receiving immunosuppressant therapy, may have reduced immune responses to
      Menveo.
 •    Persons with certain complement deficiencies and persons receiving treatment
      that inhibits terminal complement activation (for example, eculizumab) are at
      increased risk for invasive disease caused by N. meningitidis, including
      invasive disease caused by serogroups A, C, Y, and W, even if they develop
      antibodies following vaccination with Menveo.
 •    Guillain-Barré syndrome (GBS) has been reported in temporal relationship
      following administration of another US-licensed meningococcal quadrivalent
      polysaccharide conjugate vaccine. The decision to administer Menveo to
      individuals with a history of GBS should take into account the expected
      benefits and potential risks.
 •    Apnea following intramuscular vaccination has been observed in some infants
      born prematurely. A decision about when to administer Menveo to an infant born
      prematurely should be based on consideration of the individual infant's
      medical status and the potential benefits and possible risks of vaccination.
 •    Common solicited adverse reactions among children initiating vaccination: at 2
      months of age and receiving the 4-dose series were tenderness and erythema at
      injection site, irritability, sleepiness, persistent crying, change in eating
      habits, vomiting, and diarrhea; at 7 months through 23 months of age and
      receiving the 2-dose series were tenderness and erythema at injection site,
      irritability, sleepiness, persistent crying, change in eating habits, and
      diarrhea; at 2 through 10 years of age who received Menveo were injection site
      pain, erythema, irritability, induration, sleepiness, malaise, and headache.
      Common solicited adverse reactions among adolescents and adults aged 11
      through 55 years who received a single dose of Menveo were pain at the
      injection site, headache, myalgia, malaise, and nausea. Across all age groups,
      some events were severe. Similar rates of solicited adverse reactions among
      adolescents and adults were observed following a single booster dose.
 •    In two clinical studies, there were no notable differences in frequency and
      severity of solicited adverse reactions in individuals who received Menveo
      one-vial presentation compared to individuals who received the 2-vial
      presentation.
 •    Vaccination with Menveo may not result in protection in all vaccine
      recipients.

 

About GSK

GSK is a global biopharma company with a purpose to unite science, technology,
and talent to get ahead of disease together. Find out more at gsk.com/company
(https://www.gsk.com/en-gb/company/)

 

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Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made
by GSK, including those made in this announcement, are subject to risks and
uncertainties that may cause actual results to differ materially from those
projected. Such factors include, but are not limited to, those described in
the Company's Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022
and any impacts of the COVID-19 pandemic.

 

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References

 1 .      Centers for Disease Control and Prevention. Vaccine Information
Statements. Available at: Meningococcal Vaccine Information Statement | CDC
(https://www.cdc.gov/vaccines/hcp/vis/vis-statements/mening.html) .

         Accessed October 2022.

 

 

 

 

 

 

 

 

 

 

 

 

 

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