Glaxosmithkline Regulatory News (GSK)

17 Oct 2022 07:00

RNS Number : 0177D GSK PLC 17 October 2022 160

Issue: 17 October 2022, Lonon UK

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US FDA approves Menveo in a new single-vial presentation to help prevent isease cause by meningococcal bacteria serogroups A, C, Y, an W

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183 160 Single-vial presentation option removes the nee for reconstitution of Menveo before use in iniviuals 10 through years of age.

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GSK plc (LSE/NYSE: GSK) toay announce that the US Foo an Drug Aministration (FDA) has approve a new presentation of Menveo [Meningococcal (Groups A, C, Y, an W-13) Oligosaccharie Diptheria CRM197 Conjugate Vaccine] for iniviuals age 10 to years to help prevent invasive meningococcal isease cause by Neisseria meningitiis serogroups A, C, Y, an W. The Menveo one-vial presentation now comes in a reay to use single vial giving healthcare proviers a more convenient option. The Menveo one-vial presentation will initially be available to US feeral customers, with broaer availability anticipate in mi-2023.

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Invasive meningococcal isease (IMD), known as meningitis, is an uncommon but serious illness that can cause life-threatening complications or even eath.1 IMD is cause by Neisseria meningitiis, with the majority of cases cause by serogroups (A, B, C, W, Y) in most of the worl.1 Among those who contract meningitis, one in ten will ie, espite 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 amage, amputations, hearing loss an nervous system problems.1

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Roger Connor, Presient, Vaccines an Global Health, GSK, sai: "Outbreaks of this angerous isease continue to occur, impacting families, health systems an society. This FDA approval of Menveo one-vial presentation offers greater convenience to healthcare proviers to help prevent this isease in at-risk populations in the Unite States."

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The original two-vial presentation of Menveo requiring reconstitution, was approve by the FDA in 2010 an remains available for use in iniviuals from two months to years of age.

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About Menveo

The Menveo vaccine (supplie in a two-vial presentation) for meningococcal groups A, C, Y, an W has been approve in over 60 countries, with more than 72 million oses istribute worlwie since 2010. It offers extensive evience of immunogenicity an a well-characterise safety profile. Menveo oes not prevent Neisseria meningitiis serogroup B infections.

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The US Prescribing Information is available here.

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Important Safety Information for Menveo in the US

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

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Do not aminister Menveo to iniviuals with a severe allergic reaction (e.g., anaphylaxis) to a previous ose of Menveo, to any component of this vaccine, or to any other iphtheria toxoi-containing vaccine.

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Appropriate meical treatment must be available shoul an acute allergic reaction, incluing an anaphylactic reaction, occur following aministration of Menveo.

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Syncope (fainting) has occurre in association with aministration of Menveo. Proceures shoul be in place to avoi injury from fainting.

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Some iniviuals with altere immunocompetence, incluing some iniviuals receiving immunosuppressant therapy, may have reuce immune responses to Menveo.

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Persons with certain complement eficiencies an persons receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increase risk for invasive isease cause by N. meningitiis, incluing invasive isease cause by serogroups A, C, Y, an W, even if they evelop antiboies following vaccination with Menveo.

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Guillain-Barr233 synrome (GBS) has been reporte in temporal relationship following aministration of another US-license meningococcal quarivalent polysaccharie conjugate vaccine. The ecision to aminister Menveo to iniviuals with a history of GBS shoul take into account the expecte benefits an potential risks.

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Apnea following intramuscular vaccination has been observe in some infants born prematurely. A ecision about when to aminister Menveo to an infant born prematurely shoul be base on consieration of the iniviual infant's meical status an the potential benefits an possible risks of vaccination.

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Common solicite averse reactions among chilren initiating vaccination: at 2 months of age an receiving the 4-ose series were tenerness an erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, an iarrhea at 7 months through 23 months of age an receiving the 2-ose series were tenerness an erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, an iarrhea at 2 through 10 years of age who receive Menveo were injection site pain, erythema, irritability, inuration, sleepiness, malaise, an heaache. Common solicite averse reactions among aolescents an aults age 11 through years who receive a single ose of Menveo were pain at the injection site, heaache, myalgia, malaise, an nausea. Across all age groups, some events were severe. Similar rates of solicite averse reactions among aolescents an aults were observe following a single booster ose.

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In two clinical stuies, there were no notable ifferences in frequency an severity of solicite averse reactions in iniviuals who receive Menveo one-vial presentation compare to iniviuals who receive the 2-vial presentation.

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Vaccination with Menveo may not result in protection in all vaccine recipients.

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About GSK

GSK is a global biopharma company with a purpose to unite science, technology, an talent to get ahea of isease together. Fin out more at gsk.com/company

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GSK enquiries

Meia:

Tim Foley

+44 (0) 20 8047 02

(Lonon)

Simon Moore

+44 (0) 20 8047 02

(Lonon)

Alison Hunt

+1 40 742 3391

(Washington DC)

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Investor Relations:

Nick Stone

+44 (0) 7717 618834

(Lonon)

James Dowell

+44 (0) 20 8047 2406

(Lonon)

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+44 (0) 7990 33963

(Lonon)

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+44 (0) 738 41719

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+1 21 71 7002

(Philaelphia)

Frannie DeFranco

+1 21 71 48

(Philaelphia)

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Cautionary statement regaring forwar-looking statements

GSK cautions investors that any forwar-looking statements or projections mae by GSK, incluing those mae in this announcement, are subject to risks an uncertainties that may cause actual results to iffer materially from those projecte. Such factors inclue, but are not limite to, those escribe in the Company's Annual Report on Form 20-F for 2021, GSK's Q2 Results for 2022 an any impacts of the COVID-19 panemic.

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Registere in Englan Wales:

No. 3888792

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Registere Office:

980 Great West Roa

Brentfor, Milesex

TW8 9GS

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References

[1]. 160 160 160Centers for Disease Control an Prevention. Vaccine Information Statements. Available at: Meningococcal Vaccine Information Statement | CDC.160

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