FDA Approves Expanded Age Indication for Arexvy RSV Vaccine

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The expanded indication is for the prevention of respiratory syncytial virus-associated lower respiratory tract disease in adults aged 50 through 59 years who are at an increased risk.

The FDA has approved an expanded indication for the respiratory syncytial virus (RSV) vaccine Arexvy (GlasxoKlineSmith) to prevent RSV-associated lower respiratory tract disease (LRTD) in adults who are 50 through 59 years of age at an increased risk. Currently, the vaccine is approved for adults who are 60 years of age and older, and it is recommended by the CDC Advisory Committee on Immunization Practices using shared clinical decision-making.1

Arexvy contains a recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3) and is combined with a proprietary AS01E adjuvant. The FDA approved the vaccine in May 2023 for the prevention of RSV-related LRTD in patients who are 60 years of age and older, and it is also approved for this indication in 40 other countries including countries in Europe and Japan. Officials recommend that Arexvy is used in accordance with official guidelines.1

Health care provider administering vaccine -- Image credit: guerrieroale | stock.adobe.com

Image credit: guerrieroale | stock.adobe.com

Adults who have underlying medical conditions (eg, chronic obstructive pulmonary disease, asthma, heart failure, and diabetes) are at an increased risk for serious outcomes resulting from RSV infection compared with those without these conditions. Additionally, some patients with these conditions may experience RSV-induced exacerbations that can result in pneumonia, hospitalization, or death.1

“Today's approval reflects the importance of broadening the benefits of RSV immunization to adults aged 50 to 59 who are at increased risk. For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD,” said Tony Wood, chief scientific officer, GlaxoKlineSmith, in a news release.1

This updated approval comes after positive results from a placebo-controlled, observer-blind, randomized, multi-country, phase 3 immunogenicity clinical trial (NCT05590403) that evaluates the immune response and safety of Arexvy compared with placebo in 570 participants aged 50 to 59 years, including those who are at an increased risk of RSV-LRTD compared with older adults aged 60 years and older. In this trial, patients were randomly assigned to receive either 1 dose of Arexvy intramuscularly on day 1 or placebo.2

About the Trial

Trial Name: A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above

ClinicalTrials.gov ID: NCT05590403

Sponsor: GlaxoKlineSmith

Completion Date: April 3, 2024

The trial’s primary end points were RSV-A and RSV-B neutralization titers of both groups at 1 month (day 31) following vaccine administration compared with adults aged 60 years and older. Additionally, there were also safety and immunogenicity secondary and tertiary end points, including the frequency of adverse events (AEs) and serious AEs (SAEs), administration site pain, solicited systemic events, potential immune mediated disease, among others. These at a 4-day, 30-day, 1-month, 6-month, or 12-month follow-up period depending on the end point.1,2

The trial demonstrated both safety and reactogenicity data consistent with trials from initial AReSVi-006 data read out. The most common local AE reported by patients receiving Arexvy in the trial was pain, and the most common systemic AEs were myalgia, fatigue, and headache, which were primary transient and mild to moderate in severity. Other reported AEs include cardiac disorders (eg, atrial fibrillation, palpitations), gastrointestinal complications (eg, abdominal pain, diarrhea, vomiting), injection site pain, pyrexia, and infections (eg, COVID-19, influenza, upper respiratory tract infection).1,2

According to officials, trials to evaluate the immunogenicity and safety of Arexvy in adults aged 18 to 49 years who are at an increased risk as well as adults aged 18 and over who are immunocompromised are expected to read out later in 2024. GlaxoKlineSmith has also reported filing regulatory submissions to extend the updated approval of Arexvy to Europe, Japan, and other countries with regulatory decisions undergoing review.1

“I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50 to 59 [years] at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider,” said Ann R, Falsey, University of Rochester School of Medicine, in the news release. “Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them.”1

References

1. GlaxoKlineSmith. US FDA approves expanded age indication for GSK’s Arexvy, the first respiratory syncytial virus (RSV) vaccine for adults aged 50-59 at increased risk. News release. June 7, 2024. Accessed June 10, 2024. https://www.gsk.com/en-gb/media/press-releases/us-fda-approves-expanded-age-indication-for-gsk-s-arexvy-the-first-rsv-vaccine-for-adults-aged-50-59-at-increased-risk/
2. A Study on the Immune Response and Safety of a Vaccine Against Respiratory Syncytial Virus Given to Adults 50-59 Years of Age, Including Adults at Increased Risk of Respiratory Syncytial Virus Lower Respiratory Tract Disease, Compared to Older Adults 60 Years of Age and Above. ClinicalTrials.gov identifier: NCT05590403. Updated May 21, 2024. Accessed June 10, 2024. https://clinicaltrials.gov/study/NCT05590403
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