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GSK's Menveo Meningococcal Vaccine in New Single-vial, Fully Liquid Presentation Receives Positive European CHMP Opinion

GSK's Menveo Meningococcal Vaccine in New Single-vial, Fully Liquid Presentation Receives Positive European CHMP Opinion

GSK的Menveo腦膜炎球菌生物-疫苗推出新的單瓶、全液體展示形式，獲得歐洲CHMP委員會積極意見
葛蘭素史克 ·  09/24 12:00
  • If approved, the fully liquid presentation will offer healthcare providers an option that does not require reconstitution of Menveo (MenACWY vaccine) before use
  • Marketing authorisation in EU expected by November 2024
  • Over 6 million doses of GSK's MenACWY vaccine have been distributed to European countries since 2017 to help protect against invasive meningococcal disease1
  • 如果獲批，全液體配方將爲醫療保健提供者提供一個選擇，無需在使用前重新攪拌Menveo(MenACWY疫苗)
  • 預計歐盟將在2024年11月獲得營銷授權
  • 自2017年以來，已向歐洲國家分發了600萬劑GSK的MenACWY疫苗，以幫助預防侵襲性腦膜炎1

GSK plc (LSE/NYSE: GSK) today announced that the European Medicine Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended for use a single-vial, fully liquid presentation of Menveo (Meningococcal Group A, C, W-135 and Y conjugate vaccine, MenACWY vaccine) to help protect against invasive meningococcal disease (IMD) caused by bacterial groups A, C, W, and Y.

GSK plc (LSE/NYSE: GSK)今天宣佈，歐洲藥品管理局(EMA)的人用藥品委員會(Comittee for Medicinal Products for Human Use, CHMP)已建議使用Menveo (流感嗜血桿菌A、C、W-135及Y結合疫苗，MenACWY疫苗)的單瓶全液體配方，以幫助預防由A、C、W和Y細菌引起的侵襲性腦膜炎(IMD)

If approved, this single-vial presentation will be licenced for active immunisation of children from 2 years of age, adolescents and adults, offering healthcare providers an option that does not require reconstitution before its use.

如果獲批，這種單瓶配方將獲得許可用於2歲以上兒童、青少年和成年人的主動免疫，爲醫療保健提供者提供一個選擇，在使用前無需重新攪拌

Philip Dormitzer, GSK Head of Global Vaccines Research & Development, said: "As a global leader in meningococcal vaccines, we are committed to finding innovative solutions that simplify immunisation against bacterial meningitis, support vaccine uptake and help protect as many people as possible from this devastating disease. We will continue our efforts to help prevent this disease in at-risk populations in the European Union."

GSK全球疫苗研究和發展負責人Philip Dormitzer表示:「作爲腦膜炎疫苗全球領導者，我們致力於尋找簡化細菌性腦膜炎免疫、支持疫苗接受以及幫助儘可能多的人免受這種破壞性疾病影響的創新解決方案。我們將繼續努力幫助預防歐盟高危人群患上該疾病」

GSK's submission to the EMA is based on two positive Phase IIb trials (2017-003692-61; 2017-003456-23).2,3 The primary and secondary outcomes of these trials, supported by post-hoc pooled analyses, show that the fully liquid formulation of this vaccine has comparable immunogenicity, tolerability and a comparable safety profile to the existing lyophilized/liquid formulation. Today's positive opinion marks one of the final steps prior to the potential extension of the marketing authorisation by the European Commission (EC). The EC's final decision is expected by November 2024.

GSK向EMA提交的資料基於兩項積極的IIb期試驗(2017-003692-61；2017-003456-23)。這些試驗的主要和次要結局，由事後彙總分析支持，表明該疫苗的全液體配方在免疫原性、耐受性和安全性方面與現有凍幹/液體配方相當。今天的積極意見標誌着歐洲委員會(EC)在可能擴展營銷授權之前的最後一步。EC的最終決定預計將在2024年11月作出

IMD is an unpredictable but serious illness that can cause life-threatening complications.4 Despite treatment, among those who contract IMD one in six will die, sometimes in as little as 24 hours.4 One in five survivors may suffer long-term consequences such as brain damage, amputations, hearing loss and nervous system problems.4 Although anyone can get IMD, babies, young children and those who are in their late teens and early adulthood are amongst the groups at higher risk.4

IMD是一種不可預測但嚴重的疾病，可能導致危及生命的併發症。儘管接受治療，患上IMD的人中有六分之一會死亡，有時甚至在24小時內。五分之一的倖存者可能會遭受長期後果，如腦損傷、截肢、聽力喪失和神經系統問題。儘管任何人都可能患上IMD，但嬰兒、幼兒和十幾歲以及二十幾歲的人士是高風險群體之一

The original presentation of Menveo that requires reconstitution and which was approved by the EMA in 2010 is unaffected by this recommendation.5

EMA於2010年批准的需要重新配製的Menveo的原始表現不受這一建議的影響。5

About Menveo

關於Menveo

GSK's MenACWY vaccine has received regulatory approval in over 60 countries, with more than 82 million doses distributed worldwide since 2010.6,7 Over 6 million doses have been distributed to European countries since 2017.1 It offers evidence of immunogenicity with a well-characterised safety profile.8,9 In the European Union (EU), this vaccine has received regulatory approval for active immunisation to prevent IMD caused by Neisseria meningitidis serogroups A, C, Y, and W in children from 2 years of age, adolescents and adults.10 EMA Prescribing Information for Menveo can be accessed at:

葛蘭素史克（GSK）的MenACWY疫苗已在60多個國家獲得了監管批准，自2010年以來在全球分發了超過8200萬劑。6,7 自2017年以來，已向歐洲國家分發了超過600萬劑。 其提供了免疫原性證據，並具有良好的安全性特徵。8,9 在歐盟，該疫苗已獲得了預防由淋巴腦膜炎奈瑟菌群A、C、Y和W引起的活躍免疫的監管批准，適用於2歲以上的兒童、青少年和成人。10 Menveo的EMA處方信息可以在以下網址找到：

About GSK

關於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.

GSK是一家全球生物醫藥公司，其目的是通過聯合科學、技術和才華於疾病之前獲得優勢。詳情請訪問gsk.com。

Cautionary statement regarding forward-looking statements

關於前瞻性聲明的警告聲明

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 under Item 3.D "Risk factors" in GSK's Annual Report on Form 20-F for 2023, and GSK's Q2 Results for 2024.

GSk 提示投資者，GSk 在本公告中發表的任何前瞻性聲明或預測都存在風險和不確定性，可能導致實際結果與預期結果有所不同。 這些因素包括但不限於 GSK 的 2023 年年度報告表格 20-F 的第 3.D 條「風險因素」和 2024 年第二季度業績。

References

參考

  1. Data on file: Menveo doses distributed in Europe from 2017 to August 31st 2024 REF-246217
  2. EU Clinical Trials Register, A phase 2b, randomized, controlled, observer-blind, multi-center, non-inferiority immunogenicity and safety study of two formulations of GSK Biologicals' Meningococcal ACWY conjugate vaccine (GSK3536820A and Menveo) administered to healthy adults 18 to 40 years of age. Available at: . Accessed September 2024.
  3. EU Clinical Trials Register, A phase 2b, randomized, controlled, observer-blind, multi-center study to evaluate safety and immunogenicity of different formulations of GSK Biologicals' Meningococcal ACWY conjugate vaccine (GSK3536820A and Menveo) administered to healthy adolescents and young adults 10 to 40 years of age.. Available at: . Accessed September 2024.
  4. World Health Organization (WHO), Meningitis Factsheet, 2023. Available at: . Accessed September 2024.
  5. EC Decision C(2010)1795 of 16 March 2010 and subsequent amendments; marketing authorisation numbers EU/1/10/614/002 & EU/1/10/614/003
  6. Data on File; List of countries where Menveo is registered and/or commercialized REF-194949
  7. Data on File: Menveo doses distributed from 2010 to end of 2022 REF-195452
  8. Becerra-Culqui TA, Sy LS, Ackerson BK, et al. Safety of quadrivalent meningococcal conjugate vaccine in infants and toddlers 2 to 23-months old. Vaccine. 2020; 38(2), 228–234.
  9. Khatami A, Snape MD, Davis E, et al. Persistence of the immune response at 5 years of age following infant immunisation with investigational quadrivalent MenACWY conjugate vaccine formulations. Vaccine. 2012; 30:2831–2838. 10.1016/j.vaccine.2012.02.04
  10. EMA, Menveo : EPAR - Product Information – Summary of Product Characteristics. Available at: . Accessed September 2024.
  1. 文件數據：自2017年至2024年8月31日在歐洲分發的Menveo劑量 REF-246217
  2. 歐盟臨床試驗註冊，GSK生物-疫苗的腦膜炎球菌ACWY結合疫苗（GSK3536820A和Menveo），在18至40歲健康成年人中進行的第20億階段、隨機、對照、觀察者盲法、多中心、非劣效性免疫原性和安全性研究。 可在：. 查看2024年9月訪問。
  3. 歐盟臨床試驗註冊，GSK生物-疫苗的腦膜炎球菌ACWY結合疫苗（GSK3536820A和Menveo），在10至40歲健康青少年和年輕成年人中進行的第20億階段、隨機、對照、觀察者盲法、多中心研究評估安全性和免疫原性不同配方。 可在：. 訪問2024年9月。
  4. 世界衛生組織（WHO），腦膜炎簡介，2023。 可在：. 訪問2024年9月。
  5. EC決定C(2010)1795，2010年3月16日及隨後的修訂；營銷授權號碼爲EU/1/10/614/002 和 EU/1/10/614/003
  6. 文件數據；Menveo在各國註冊和/或商業化的名單 REF-194949
  7. 文件數據：從2010年到2022年底分發的Menveo劑量 REF-195452
  8. Becerra-Culqui 長益，Sy LS, Ackerson Bk等。四價腦膜炎球菌結合疫苗在2至23個月大嬰兒和幼兒中的安全性。生物-疫苗。2020年； 38（2），228–234。
  9. Khatami A, Snape MD, Davis E等人。研究四價MenACWY縮合疫苗配方，嬰兒接種後5年的免疫持久性。生物-疫苗。2012; 30:2831–2838. 10.1016/j.vaccine.2012.02.04
  10. EMA, Menveo: EPAR-產品信息-產品特性摘要。網址：。2024年9月查閱。

譯文內容由第三人軟體翻譯。


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