FDA Greenlights AREXVY by GSK: First RSV Vaccine for High-Risk Adults 50-59

GSK plc announced today that the US Food and Drug Administration (FDA) has given the green light to AREXVY (Respiratory Syncytial Virus (RSV) Vaccine, Adjuvanted) for the prevention of RSV lower respiratory tract disease (LRTD) in adults aged 50 through 59 years who are at increased risk. This expands the age range for which the vaccine is approved in the US. Currently, the vaccine is approved for individuals aged 60 and older and is recommended for those aged 50-59 using shared clinical decision-making by CDC/ACIP.

According to a systematic review of US studies, RSV causes an estimated 42,000 hospitalizations annually among adults aged 50-64 years. Individuals with underlying medical conditions like chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes are at higher risk of severe consequences from an RSV infection compared to those without these conditions. RSV can worsen these conditions and lead to pneumonia, hospitalization, or even death.

Tony Wood, Chief Scientific Officer at GSK, emphasized the significance of broadening the benefits of RSV immunization to adults aged 50-59 at increased risk. He highlighted the serious consequences RSV can have for individuals with underlying medical conditions and expressed pride in offering protection against RSV-LRTD.

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

Professor Ann R. Falsey from the University of Rochester School of Medicine expressed delight at the approval of GSK’s RSV vaccine for adults aged 50-59 at increased risk of RSV-LRTD. She stressed that age is a crucial factor, but not the sole one, in assessing the risks associated with RSV. Many individuals in this age group have underlying health conditions that elevate their risk of severe illness from RSV infection, and now there’s a vaccine available to protect them.

GSK has also submitted regulatory applications to extend the use of its RSV vaccine to adults aged 50-59 at increased risk in Europe, Japan, and other regions, with decisions pending review. Trials evaluating the vaccine’s immunogenicity and safety in adults aged 18-49 at increased risk and immunocompromised adults aged 18 and over are anticipated to yield results in the second half of 2024.

About AREXVY (Respiratory Syncytial Virus Vaccine, Adjuvanted):

AREXVY contains 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 the prevention of lower respiratory tract disease (LRTD) caused by RSV in individuals 60 years of age and older. Its use should align with official recommendations. As with any vaccine, not all recipients may develop a protective immune response.

The vaccine has been approved for preventing RSV-LRTD in individuals 60 years of age and older in over 40 countries, including Europe, Japan, and the US, with regulatory reviews ongoing in multiple countries. The proposed trade name is subject to regulatory approval in other markets.

The GSK proprietary AS01 adjuvant system includes 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 for preventing lower respiratory tract disease (LRTD) caused by RSV in:

Individuals 60 years of age and older. Individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV.

Important Safety Information for AREXVY:

AREXVY is contraindicated in individuals with a history of severe allergic reactions to any component of the vaccine. Immediate medical treatment should be available to manage potential anaphylactic reactions following vaccination. Syncope (fainting) may occur after vaccination, necessitating precautions to prevent injury. Immunocompromised persons, including those receiving immunosuppressive therapy, may have a reduced immune response to AREXVY. Commonly reported adverse reactions in adults 60 years of age and older include injection site pain, fatigue, myalgia, headache, and arthralgia. Commonly reported adverse reactions in adults 50 through 59 years of age include injection site pain, fatigue, myalgia, headache, arthralgia, erythema, and swelling. There is insufficient data on the use of AREXVY in pregnant and breastfeeding individuals, and it is not approved for use in persons under 50 years of age.

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