You are now leaving GSK’s website

You are now leaving a GSK Website. By clicking this link, you will be taken to a website that is not owned or controlled by GSK, and GSK is not responsible for the content provided on that site.

Continue

Go back

AREXVY LOGO

Product menu

EFFICACY

Demonstrated 82.6% efficacy against RSV-LRTD for patients aged 60 years and older and 94.6% for patients with at least 1 comorbidity of interest aged 60 years and older.1

82.6%

PRIMARY ENDPOINT

82.6% OVERALL EFFICACY IN PROTECTING AGAINST RSV-LRTD

(96.95% CI, 57.89, 94.08)

AREXVY (7 cases out of 12,466), placebo (40 cases out of 12,494)

94.6%

SECONDARY ENDPOINT

94.6% EFFICACY IN PROTECTING AGAINST RSV-LRTD FOR PATIENTS WITH AT LEAST 1 COMORBIDITY OF INTEREST1

(95% CI, 65.88, 99.87)

AREXVY (1 case out of 4937),
placebo (18 cases out of 4861)

Study 1, an ongoing phase 3 study, randomised participants ≥60 years of age to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). Median follow-up for this analysis was 6.7 months.1

  • The efficacy of AREXVY against RSV-associated LRTD in adults 60 years and older was evaluated in an ongoing, phase 3, randomised, placebo-controlled, observer-blind clinical study conducted in 17 countries from Northern and Southern Hemispheres. Participants are planned to be followed for up to 36 months.

    The primary population for efficacy analysis (referred to as the modified exposed set, which included adults 60 years of age and older receiving 1 dose of AREXVY or placebo who did not report an RSV-confirmed acute respiratory infection (ARI) prior to Day 15 after vaccination) included 24,960 participants randomised equally to receive 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of the primary efficacy analysis, participants had been followed for the development of RSV-associated LRTD for up to 10 months (median of 6.7 months).

    At baseline, 39.3% of participants had at least 1 comorbidity of interest; 19.7% of participants had an underlying cardiorespiratory condition (COPD, asthma, any chronic respiratory/pulmonary disease, or chronic heart failure) and 25.8% of participants had endocrinometabolic conditions (diabetes, advanced liver or renal disease).

    Definition: RSV-LRTD
    Respiratory syncytial virus–associated lower respiratory tract disease (RSV-LRTD) was defined as at least 2 lower respiratory symptoms/signs, including at least 1 lower respiratory sign for at least 24 hours, or at least 3 lower respiratory symptoms for at least 24 hours.1

    Lower respiratory symptoms included: new or increased sputum, new or increased cough, new or increased dyspnea (shortness of breath). Lower respiratory signs included: new or increased wheezing, crackles/rhonchi, respiratory rate ≥20 respirations/min, low or decreased oxygen saturation (O2 saturation <95% or ≤90% if baseline is <95%), need for oxygen supplementation.1

    Definition: Severe RSV-LRTD
    Severe RSV-associated LRTD was defined as RT-PCR–confirmed RSV-associated LRTD with at least 2 lower respiratory signs, or as an RT-PCR–confirmed RSV-associated LRTD episode assessed as 'severe' by the investigator.1

    Definition: RSV-ARI
    Acute respiratory infection (ARI) was defined by the presence of at least 2 respiratory symptoms/signs for at least 24 hours, or at least 1 respiratory symptom/sign plus 1 systemic symptom/sign (fever or feverishness, fatigue, body aches, headache, decreased appetite) for at least 24 hours.1

Efficacy was established in patients with at least 1 comorbidity of interest1:

woman standing with hands together with lungs illuminated

COPD, asthma, or any chronic respiratory/pulmonary disease

man standing with his arms crossed with heart illuminated

Chronic heart failure

man sitting down with liver illuminated

Diabetes mellitus type 1
or type 2

woman sitting down with cane

Advanced liver or renal disease

Not actual patients.

shield

SAFETY

AREXVY was generally well tolerated with an acceptable safety profile. Review the safety findings now.1

LEARN MORE
shield blocking particle

SECONDARY ANALYSES

AREXVY showed consistent high efficacy in protecting against RSV-LRTD observed across secondary endpoints.1

LEARN MORE
two vials and a syringe

ADMINISTRATION

Review details on dosing and administration of AREXVY to learn about the reconstitution process.

LEARN MORE

Abbreviations

COPD=chronic obstructive pulmonary disease;
LRTD=lower respiratory tract disease; RSV=respiratory syncytial virus.

References

  1. Papi A, Ison MG, Langley JM, et al., for the AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med.202;388(7):595-608. doi:10.1056/ NEJMoa2209604.
  2. Arexvy SPC, available from https://www.medicines.ie/medicines/arexvy-powder-and-suspension-for-suspension-for-injection-35441/spc. Accessed April 2024

Adverse events should be reported directly to the Health Products Regulatory Authority (HPRA) on their website: www.hpra.ie. Adverse events should also be reported to GlaxoSmithKline on 1800 244 255.

▼This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

Arexvy is a registered trademark of the GlaxoSmithKline group of companies.

©2024 GSK group of companies. All rights reserved

PM-IE-ABX-WCNT-230002 | May 2024