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NOW APPROVED

Efficacy demonstrated against RSV-LRTD* for patients aged 60 years and older1

OVERALL EFFICACY AGAINST RSV-LRTD*

82.6%

(96.95% CI, 57.9, 94.1)

PRIMARY ENDPOINT1

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

EFFICACY AGAINST RSV-LRTD* IN PARTICIPANTS WITH AT LEAST 1 COMORBIDITY OF INTEREST**

94.6%

(95% CI, 65.9, 99.9)

SECONDARY ENDPOINT1

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

*Vaccination does not protect all recipients1
**comorbidities of interest2: Chronic obstructive pulmonary disease (COPD), asthma, any other chronic respiratory/pulmonary disease, chronic heart failure, diabetes mellitus type 1 or type 2 or liver or renal diseases (endocrinometabolic).1
Study Design2: AReSVi-006, an ongoing, phase 3, randomized, placebo-controlled, observer-blind study in adults aged 60 years, evaluated the efficacy of AREXVY in preventing RSV-LRTD during the first season. Participants in the primary population for efficacy analysis received 1 dose of AREXVY (n=12,466) or placebo (n=12,494). At the time of this analysis, median follow-up was 6.7 months.
CI= Confidence Interval ; LRTD= lower respiratory tract disease; RSV= respiratory syncytial virus.

Efficacy was established in patients with at least 1 comorbidity of interest:2

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.

Administration and storage

  • Arexvy is supplied as 2 vials. The powder and suspension must be reconstituted before administration.1
  • Administer 1 dose (0.5 ml) of Arexvy as an intramuscular injection, preferably in the deltoid muscle.1
  • Arexvy can be administered concomitantly with seasonal influenza vaccine (quadrivalent; standard dose, unadjuvanted, inactivated).1
  • Arexvy should be refrigerated. DO NOT FREEZE (discard if frozen).1

VIEW FULL PRESCRIBING INFORMATION

syringe et vials

Safety Profile

Clinically acceptable safety profile

In study participants 60 years of age and older, the most commonly reported adverse reactions were injection site pain (61%), fatigue (34%), myalgia (29%), headache (28%), and arthralgia (18%). These adverse reactions were usually mild or moderate in intensity and resolved within a few days after vaccination. Most other adverse reactions were uncommon and similarly reported between the study groups1 

Percentage of participants with solicited local and systemic adverse reactions within 4 days of vaccination in adults aged 60 years and older (solicited safety set with 4-day diary card, N=1757)2,3

 

AREXVY %

Placeboa %

Local Adverse Reactions

N=879

N=874

Pain, Anyb

60.9

9.3

Pain, Grade 3b

1

0

Erythema, >20 mm

7.5

0.8

Erythema, >100 mm

0.2

0

Swelling, >20 mm

5.5

0.6

Swelling, >100 mm

0.2

0

 

AREXVY %

Placeboa %

Systemic Adverse Reactions

N=879

N=878

Fatigue, Anyc

33.6

16.1

Fatigue, Grade 3c

1.7

0.5

Myalgia, Anyc

28.9

8.2

Myalgia, Grade 3c

1.4

0.3

Headache, Anyc

27.2

12.6

Headache, Grade 3c

1.3

0

Arthralgia, Anyc

18.1

6.4

Arthralgia, Grade 3c

1.3

0.6

Fever, ≥38.0 °C/100.4 °Fd

2.0

0.3

Fever, >39.0 °C/102.2 °Fd

0.1

0.1

N=exposed set for solicited safety set included all participants with at least 1 documented dose.
aPlacebo was a saline solution.
bAny grade pain: Defined as any pain neither interfering with nor preventing normal everyday activities (Grade 1), painful when limb is moved and interferes with everyday activities (Grade 2), or significant pain at rest and prevents normal everyday activities (Grade 3).
cAny grade fatigue, myalgia, headache, arthralgia: Defined as event easily tolerated (Grade 1), interfering with normal activity (Grade 2), or preventing normal activity (Grade 3).
dTemperature taken by any route (oral, axillary, or tympanic).

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Abbreviations:
RSV=respiratory syncytial virus; RSV-LRTD=respiratory syncytial virus-associated lower respiratory tract disease.

References:

  1. Arexvy Summary of product Characteristics Available from https://www.medicines.ie/medicines/arexvy-powder-and-suspension-for-suspension-for-injection-35441/spc#tabs
  2. Papi A, lson MG, Langley JM, et for the AReSVi-006 Study Group. Respiratory syncytial virus prefusion F protein vaccine in older adults. N Engl J Med. 2023;388(7):595-608. doi:10.1056/NEJMoa2209604
  3. Arexvy CHMP assessment report, European Medicines Agency (EMA) April 2023

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.

©2023 GSK group of companies. All rights reserved.

PM-IE-ABX-WCNT-230001 | August 2023