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US FDA approves GSK’s Arexvy, the world’s first respiratory syncytial virus (RSV) vaccine for older adults

Thursday, May 04, 2023

GSK has announced that the FDA has granted approval for Arexvy, an adjuvanted respiratory syncytial virus (RSV) vaccine, for the prevention of lower respiratory tract disease caused by RSV in individuals aged 60 and above. This approval marks a significant milestone in reducing the burden of RSV, as it is the first vaccine specifically for older adults to be approved globally.

Tony Wood, Chief Scientific Officer at GSK, expressed the importance of this achievement, stating that Arexvy expands GSK's leading vaccine portfolio, which safeguards millions of people against infectious diseases annually. GSK's focus now is to ensure that eligible older adults in the US can access the vaccine promptly and progress with regulatory reviews in other countries.

RSV is a contagious virus that can lead to severe respiratory illness. It is responsible for approximately 177,000 hospitalizations and around 14,000 deaths among adults aged 65 and older in the US each year. Older adults, especially those with underlying medical conditions like diabetes, chronic heart and lung diseases, are at higher risk of experiencing severe RSV illness and account for the majority of RSV-related hospitalizations.

Dr. John Kennedy, President of the American Medical Group Association (AMGA), commended the addition of an RSV vaccine to the options available for patient care. He emphasized the significance of this vaccine in protecting Americans over the age of 60, particularly those with underlying health conditions such as COPD, asthma, or congestive heart failure, against potential serious outcomes from RSV.

The FDA approval of Arexvy is based on the positive results of GSK's pivotal AReSVi-006 phase III trial. The vaccine demonstrated a statistically significant and clinically meaningful overall efficacy of 82.6% against RSV-LRTD (respiratory syncytial virus lower respiratory tract disease) in adults aged 60 and older, meeting the primary endpoint. Moreover, the efficacy was 94.6% in older adults with at least one underlying medical condition of interest. The vaccine also exhibited a 94.1% efficacy against severe RSV-LRTD, defined as an episode of RSV-associated lower respiratory tract disease that hindered normal daily activities.

The vaccine was generally well tolerated, with mild to moderate and transient solicited adverse events such as injection site pain, fatigue, myalgia, headache, and arthralgia.

The Advisory Committee on Immunization Practices (ACIP) is scheduled to make recommendations on the appropriate use of the vaccine in the US in June 2023. It is anticipated that the vaccine will be available for older adults before the 2023/24 RSV season, which typically begins before the winter months.

In April 2023, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion recommending the vaccine for the prevention of RSV-LRTD in adults aged 60 and older. A final decision from European regulators is expected soon, while ongoing regulatory reviews are taking place in Japan and several other countries.

Arexvy, an adjuvanted respiratory syncytial virus vaccine, contains a recombinant subunit prefusion RSV F glycoprotein antigen (RSVPreF3) combined with GSK's proprietary AS01E adjuvant. Currently, Arexvy is indicated for the prevention of RSV-LRTD in individuals aged 60 and older in the US. The trade name is subject to regulatory approval outside the US.

GSK is also conducting a clinical trial to expand the population that may benefit from RSV vaccination, specifically targeting adults aged 50-59, including those with underlying comorbidities. Results from this trial, along with additional data from the AReSVi-006

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