GSK Announces AREXVY, Its Respiratory Syncytial Virus (RSV) Vaccine, Is Now Available at All Major US Retail Pharmacies
17 August 2023 - 10:00PM
Business Wire
- Ahead of the fall and winter RSV season, AREXVY is now widely
available in major retail pharmacies and anticipated to be covered
by most Medicare and commercial insurance plans
GSK plc (LSE/NYSE: GSK) today announced that AREXVY (Respiratory
Syncytial Virus Vaccine, Adjuvanted) is now available in the US at
all major retail pharmacies. In June, the Advisory Committee on
Immunization Practices (ACIP) recommended that persons 60 years of
age and older may receive a single dose of RSV vaccine, using
shared clinical decision making. Shared clinical decision making
empowers patients, in consultation with their healthcare providers,
to decide whether RSV vaccination is appropriate for them. AREXVY
is indicated for the prevention of RSV-lower respiratory tract
disease (LRTD) in individuals aged 60 years and older.
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Under the Inflation Reduction Act, patients with Medicare Part D
will pay no out-of-pocket expenses. As part of the Affordable Care
Act, AREXVY may be covered for commercially insured patients at no
cost when administered in-network. Patients should ask their doctor
or pharmacist if AREXVY is covered.
Rob Truckenmiller, Senior Vice President, Head of US
Vaccines, GSK, said: “We are excited to announce that AREXVY is
now available to older adults in major retail pharmacies across the
US ahead of this year’s RSV season. As the makers of the first
FDA-approved RSV vaccine for older adults, we’re hopeful that RSV
vaccines, like AREXVY, will help reduce the considerable clinical,
economic, and human impact that RSV has on older adults and our
public health system.”
There are an estimated 76.5 million people aged 60 and older in
the US.1 Older adults, including those with underlying medical
conditions, such as chronic heart disease, chronic lung disease or
diabetes, are at increased risk for RSV-associated
hospitalization.2 RSV causes approximately 177,000 hospitalizations
and an estimated 14,000 deaths in adults aged 65 and older in the
US each year.3 For adults 60 and older, data suggest an increased
risk for severe RSV infection that can lead to
hospitalization.4,5
About AREXVY (Respiratory Syncytial Virus Vaccine,
Adjuvanted)
AREXVY, contains recombinant respiratory syncytial virus
glycoprotein F stabilized in the prefusion conformation (RSVPreF3).
This antigen is combined with GSK’s proprietary AS01E
adjuvant.6
AREXVY was approved by the US Food and Drug Administration (FDA)
on May 3rd, 2023, for the prevention of lower respiratory tract
disease (LRTD) caused by respiratory syncytial virus (RSV) in
adults aged 60 and older. It was the world’s first vaccine for RSV
for older adults, a common, contagious virus that can lead to
serious respiratory illness.7
In clinical trials, the vaccine was generally well tolerated.
The most frequently observed solicited adverse events were
injection site pain, fatigue, myalgia, headache, and arthralgia.
These were generally mild to moderate and transient.6
The GSK proprietary AS01 adjuvant system contains QS-21 STIMULON
adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of
Agenus Inc.
Please see the full US Prescribing Information.
Important Safety Information for AREXVY The following is
based on the US Prescribing Information for AREXVY. Please consult
the full Prescribing Information for all the labelled safety
information.
- AREXVY is contraindicated in anyone with a history of a severe
allergic reaction (eg, anaphylaxis) to any component of AREXVY
- Appropriate medical treatment and supervision must be available
to manage possible anaphylactic reactions following administration
of AREXVY
- Syncope (fainting) may occur in association with administration
of injectable vaccines, including AREXVY. Procedures should be in
place to avoid injury from fainting
- Immunocompromised persons, including those receiving
immunosuppressive therapy, may have a diminished immune response to
AREXVY
- The most commonly reported adverse reactions (≥10%) were
injection site pain (60.9%), fatigue (33.6%), myalgia (28.9%),
headache (27.2%), and arthralgia (18.1%)
- Vaccination with AREXVY may not result in protection of all
vaccine recipients
About RSV in older adults RSV is a common contagious
virus affecting the lungs and breathing passages.8 Older adults are
at high risk for severe disease due in part to age-related decline
in immunity8, and older adults with underlying conditions are also
at high risk for severe disease.4 RSV can exacerbate conditions,
including chronic obstructive pulmonary disease (COPD), asthma, and
chronic heart failure and can lead to severe outcomes, such as
pneumonia, hospitalization, and death.9 Each year, approximately
177,000 adults 65 years and older are hospitalized in the US due to
RSV; an estimated 14,000 cases result in death.3 For adults 60 and
older, data suggest an increased risk for severe RSV infection that
can lead to hospitalization.4,5 Adults with underlying conditions
are more likely to seek medical services and have higher
hospitalization rates than adults without these conditions.4
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.
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 under Item 3.D
"Risk factors” in the company's Annual Report on Form 20-F for
2022, and Q2 Results for 2023 and any impacts of the COVID-19
pandemic.
Registered in England & Wales: No. 3888792
Registered Office: 980 Great West Road Brentford,
Middlesex TW8 9GS
References
- United States Department of Health and Human Services.
Administration for Community Living. 2021 Profile of Older
Americans. November 2022. Accessed August 2023. Available at:
https://acl.gov/sites/default/files/Profile%20of%20OA/2021%20Profile%20of%20OA/2021ProfileOlderAmericans_508.pdf
- Melgar M, Britton A, Roper LE, et al. Use of Respiratory
Syncytial Virus Vaccines in Older Adults: Recommendations of the
Advisory Committee on Immunization Practices — United States, 2023.
MMWR Morb Mortal Wkly Rep 2023;72:793–801. DOI:
http://dx.doi.org/10.15585/mmwr.mm7229a4.
- Falsey AR, et al. Respiratory syncytial virus infection in
elderly and high-risk adults. N Engl J Med 2005;
352:1749-1759.
- Tseng HF, et al. Severe morbidity and short- and mid- to
long-term mortality in older adults hospitalized with respiratory
syncytial virus infection. J Infect Dis. 2020;222(8):1298-1310.
doi:10.1093/infdis/jiaa361.
- Belongia EA, et al. Clinical features, severity, and incidence
of RSV illness during 12 consecutive seasons in a community cohort
of adults ≥60 years old. Open Forum Infect Dis. 2018;5(12):ofy316.
doi:10.1093/ofid/ofy316.
- Papi et al. Respiratory Syncytial Virus Prefusion F Protein
Vaccine in Older Adults. N Engl J Med 2023; 388:595-608.
- US FDA news release. Issued 3 May 2023. Available at:
www.fda.gov/news-events/press-announcements/fda-approves-first-respiratory-syncytial-virus-rsv-vaccine
- National Foundation for Infectious Diseases. Respiratory
Syncytial Virus. Accessed August 2023. Available at:
www.nfid.org/infectious-disease/rsv/
- Centers for Disease Control and Prevention. RSV in Older Adults
and Adults with Chronic Medical Conditions. Accessed August 2023.
Available at: www.cdc.gov/rsv/high-risk/older-adults.html
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