FDA Clears GSK’s AREXVY for Adults 50-59: Expanded RSV Vaccine Use

GSK plc (LSE/NYSE: GSK) announced today that the US Food and Drug Administration (FDA) has granted approval for AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) to prevent RSV lower respiratory tract disease (LRTD) in adults aged 50 through 59 who are at heightened risk. This expansion supplements the existing approval for individuals aged 60 and above and aligns with CDC/ACIP recommendations, utilizing shared clinical decision-making.

Research in the US indicates that RSV causes an estimated 42,000 hospitalizations annually among adults aged 50-64. Individuals with underlying health conditions like chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes face elevated risks of severe outcomes from RSV infection compared to those without such conditions. RSV can worsen these conditions and result in pneumonia, hospitalization, or death.

Tony Wood, Chief Scientific Officer at GSK, commented, “This approval underscores the importance of extending RSV immunization benefits to at-risk adults aged 50-59. For those with underlying health conditions, RSV poses serious risks, so we are proud to offer protection against RSV-LRTD.”

The regulatory submission drew support from positive outcomes in a phase III trial [NCT05590403], assessing the immune response and safety of GSK’s RSV vaccine in adults aged 50-59, particularly those at heightened risk due to specific underlying medical conditions.

Professor Ann R. Falsey from the University of Rochester School of Medicine expressed excitement about the approval, stating, “I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. Age is a crucial factor, but not the sole consideration regarding RSV risks. Many adults in this age group have underlying health conditions elevating their vulnerability to severe illness from RSV infection. Now, there’s an approved vaccine to safeguard them.”

GSK has also initiated regulatory filings to extend RSV vaccine usage to at-risk adults aged 50-59 in Europe, Japan, and other regions, with regulatory reviews underway. Trials assessing vaccine efficacy and safety in at-risk adults aged 18-49 and immunocompromised adults aged 18 and over are expected to conclude in the second half of 2024.

About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted)

AREXVY comprises recombinant RSV glycoprotein F stabilized in the prefusion conformation (RSVPreF3) combined with GSK’s proprietary AS01E adjuvant.

In May 2023, the FDA approved GSK’s RSV vaccine for preventing lower respiratory tract disease (LRTD) caused by RSV in individuals aged 60 and above. Usage aligns with official recommendations. As with any vaccine, not all recipients may develop a protective immune response.

AREXVY has also received approval for preventing RSV-LRTD in individuals aged 60 and above in over 40 countries, including Europe, Japan, and the US, with regulatory reviews ongoing in multiple countries. The proposed trade name remains subject to regulatory approval in other markets.

The GSK proprietary AS01 adjuvant system contains STIMULON QS-21 adjuvant licensed from Antigenics Inc, a wholly owned subsidiary of Agenus Inc. STIMULON is a trademark of SaponiQx Inc., a subsidiary of Agenus.

Indication for AREXVY

AREXVY is indicated for active immunization to prevent lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in:

Individuals aged 60 and above. Individuals aged 50 through 59 at increased risk for RSV-LRTD. Important Safety Information for AREXVY

AREXVY is contraindicated in individuals with a history of severe allergic reactions to any AREXVY component. Immediate medical treatment should be available to manage potential anaphylactic reactions post-AREXVY administration. Syncope (fainting) may occur with injectable vaccines, including AREXVY. Measures should be in place to prevent injury. Immunocompromised individuals may have a diminished immune response to AREXVY. Commonly reported adverse reactions in adults aged 60 and above (≥10%) include injection site pain, fatigue, myalgia, headache, and arthralgia. Commonly reported adverse reactions in adults aged 50-59 (≥10%) include injection site pain, fatigue, myalgia, headache, arthralgia, erythema, and swelling. AREXVY use in pregnant and breastfeeding individuals is not established. It is not approved for use in persons <50 years old. Vaccination with AREXVY may not guarantee protection for all recipients. For full Prescribing Information, please refer to the product documentation.

NCT05590403 is a phase III, placebo-controlled, observer-blind, randomized, multi-country immunogenicity trial evaluating the immune response and safety of GSK’s RSV vaccine in participants aged 50 to 59, including those at increased risk for RSV-LRTD compared to older adults aged 60 and above after a single dose. The study included participants with pre-defined stable chronic diseases and those without. Primary endpoints included RSV-A and RSV-B neutralization titers at one month post-vaccination, along with safety and reactogenicity data consistent with previous findings. Trial results have been presented at relevant conferences and submitted for publication and regulatory review.

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