REG - GSK PLC - EMA accepts GSK RSV older adult vaccine for review

GSKAnnouncement

28/10/2022 07:01

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RNS Number : 4237E  GSK PLC  28 October 2022

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 AS01(E) 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
(https://www.gsk.com/en-gb/about-us/) .

 

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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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