UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
 
Form 6-K
 
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
 
 
 
For the month of October 2022
 
Commission File Number 001-15170
 
 
GSK plc
(Translation of registrant's name into English)
 
 
980 Great West Road, Brentford, Middlesex, TW8 9GS
(Address of principal executive office)
 
 
 
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
 
Form 20-F . . . .X. . . . Form 40-F . . . . . . . .
 
 
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ____
 
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ____
 
 
 
 
Issued: 28 October 2022, London UK
 
GSK marketing authorisation application for respiratory syncytial virus older adult vaccine candidate accepted by European Medicines Agency under accelerated assessment
 
 
●
Application based on positive pivotal phase III data showing vaccine efficacy against respiratory syncytial virus-lower respiratory tract disease in adults aged 60 years and above with a favourable safety profile
●
This is the second major regulatory milestone for the vaccine candidate following acceptance of a submission in Japan

 

 
GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) has validated the marketing authorisation application (MAA) for its respiratory syncytial virus (RSV) older adult vaccine candidate.  
 
MAAs may be eligible for accelerated assessment if the EMA's Committee for Medicinal Products for Human Use decides the product is of major interest for public health and therapeutic innovation. A European regulatory decision is anticipated in Q3 2023. If approved, GSK's RSV older adult vaccine candidate has the potential to be the first vaccine available to help protect older adults from RSV lower respiratory tract disease (LRTD).
 
The MAA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial, which showed high overall vaccine efficacy against RSV LRTD in adults aged 60 years and above. The vaccine was well tolerated with a favourable safety profile. The most frequent observed solicited adverse events were injection site pain, fatigue, myalgia, and headache. Consistent high vaccine efficacy was observed against LRTD in severe disease, adults aged 70-79 years, adults with underlying comorbidities and across RSV A and B strains.
 
This is the second major regulatory development for GSK's RSV older adult vaccine candidate following Japanese regulatory submission acceptance in October 2022. GSK's RSV older adult vaccine candidate contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant. There are currently no RSV vaccines for older adults approved anywhere in the world.
 
About the AReSVi-006 trial
The AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial is a randomised, placebo-controlled, observer-blind, multi-country trial to demonstrate the efficacy of a single dose of GSK's adjuvanted RSVPreF3 older adult investigational vaccine in adults aged 60 years and above. Approximately 25,000 participants were enrolled from 17 countries.
 
The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc.
 
About RSV in adults
RSV is a common contagious virus affecting the lungs and breathing passages. It is one of the major remaining infectious diseases for which there is currently no vaccine or specific treatment available for adults. In adults, RSV infection is typically mild, but may lead to severe outcomes. Older adults are at high risk for severe disease due to age-related decline in immunity and underlying conditions. RSV can exacerbate conditions, including chronic obstructive pulmonary disease, asthma and chronic heart failure and can lead to severe outcomes, such as pneumonia, hospitalisation, and death. Each year, RSV causes over 420,000 hospitalisations and 29,000 deaths in adults aged 60 years and above in industrialised countries. Adults with underlying conditions are more likely to seek medical advice and have higher hospitalisation rates than adults without these conditions.
 
 
 
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.
 
GSK enquiries
 
 
 
Media:
Tim Foley
+44 (0) 20 8047 5502
(London)
 
Simon Moore
+44 (0) 20 8047 5502
(London)
 
Kathleen Quinn
+1 202 603 5003
(Washington DC)
 
Alison Hunt
+1 540 742 3391
(Washington DC)
 
 
 
 
Investor Relations:
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+44 (0) 7717 618834
(London)
 
James Dodwell
+44 (0) 20 8047 2406
(London)
 
Mick Readey
+44 (0) 7990 339653
(London)
 
Josh Williams
+44 (0) 7385 415719
(London)
 
Jeff McLaughlin
+1 215 751 7002
(Philadelphia)
 
Frannie DeFranco
+1 215 751 4855
(Philadelphia)
 
 
 
 
 
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.
 
 
Registered in England & Wales:
No. 3888792
 
 
Registered Office:
980 Great West Road
Brentford, Middlesex
TW8 9GS
 
 
 
 
SIGNATURES
 
 
 
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorised.
 
GSK plc
 
(Registrant)
 
 
Date: October 28, 2022
 
 
 
 
By:/s/ VICTORIA WHYTE
--------------------------
 
 
 
Victoria Whyte
 
Authorised Signatory for and on
 
behalf of GSK plc
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