REG - GSK PLC - GSK RSV vaccine: US FDA Priority Review

GSKAnnouncement

02/11/2022 07:00

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RNS Number : 9919E  GSK PLC  02 November 2022

Issued: 2 November 2022, London UK

 

GSK's respiratory syncytial virus older adult vaccine candidate granted
Priority Review by US FDA

 

 ●    US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023
 ●    This is the third major regulatory milestone for the vaccine candidate
      following acceptance of regulatory submissions in Europe and Japan
 ●    Vaccine candidate has the potential to be the first available to help protect
      adults aged 60 years and older from lower respiratory tract disease caused by
      respiratory syncytial virus

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug
Administration (FDA) has accepted a Biologics License Application (BLA) and
granted Priority Review for its respiratory syncytial virus (RSV) older adult
vaccine candidate.

 

The US FDA grants Priority Review to applications for vaccines that, if
approved, would offer significant improvements in the safety or effectiveness
of the treatment or prevention of serious conditions when compared to standard
applications. A Priority Review designation means the US FDA's goal is to
expedite review of a BLA, reducing the review period by four months. The
Prescription Drug User Fee Act date, the FDA action date for their regulatory
decision, is 3 May 2023. If approved, GSK's RSV older adult vaccine candidate
has the potential to be the first vaccine available to help protect adults
aged 60 years and older from lower respiratory tract disease caused by RSV
infection.

 

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 (COPD), asthma and chronic heart failure
and can lead to severe outcomes, such as pneumonia, hospitalisation, and
death.

 

The BLA 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 lower respiratory tract
disease (LRTD) in adults aged 60 years and older. 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 third major regulatory milestone for GSK's RSV older adult vaccine
candidate following regulatory submission acceptances by the European
Medicines Agency and Japan's Ministry of Health, Labour and Welfare. 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 COPD, 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 older in
industrialised countries, including approximately 177,000 and 14,000,
respectively in the US. 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 when issued GSK's Q3 Results for 2022, and any impacts of the COVID-19
pandemic.

 

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