Arexvy: GSK's RSV Vaccine Receives FDA Approval to Extend Its Use to High-Risk Adults in 50s

By Trisha Andrada

Jun 08, 2024 06:20 AM EDT

GSK announced on Friday, June 7, that the Food and Drug Administration (FDA) has expanded the approval of its respiratory syncytial virus (RSV) vaccine, Arexvy, to those aged 50 to 59.

In a press release, GSK said this age group is known to be at a higher risk for serious illness with RSV lower respiratory tract disease. Arexvy is the first vaccination against RSV to be approved by the FDA for this specific demographic.

The FDA first authorized the vaccine in May 2023 to protect against severe instances of the virus in people aged 60 and above.

A Glaxo Smith Kline (GSK) signboard is displayed outside their facilities in Shanghai on July 25, 2013. (Photo : STR/AFP via Getty Images)

Thousands of Hospitalizations, Fatalities Due to RSV

The Centers for Disease Control and Prevention (CDC) said that about 60,000 to 160,000 elderly Americans are hospitalized from RSV infection each year, while 6,000 to 10,000 have died.

Viruses may also cause serious sickness in people who are 50 and older or even younger if they have preexisting chronic diseases like diabetes, asthma, or heart failure.

According to Phil Dormitzer, director of vaccines research and development and infectious disease research at GSK, about 13 million Americans between the ages of 50 and 59 are at a high risk of serious illness due to RSV.

With this new FDA approval, he told CNBC that it would be now easier for pharmacists to deliver a single vaccination to more people.

However, that new demographic would not be able to get GSK's injection just yet. A CDC advisory panel will vote on vaccine recommendations later this month.

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RSV Market Dominance May Continue for GSK

With the FDA's expanded clearance, GSK could continue dominating the RSV market later this year. Compared to Pfizer's vaccination, which brought in $890 million in revenue last year, GSK's injection made roughly $1.5 billion, according to CNBC.

During a May earnings call, GSK Chief Commercial Officer Luke Miels said that the company is still quite optimistic about Arexvy's ability to achieve peak yearly sales of over $3.8 billion.

Dormitzer also acknowledged that GSK had a successful RSV season last year but stressed that the company takes competition very seriously.

GSK hoped to increase the shot's reach in the future by investigating Arexvy in more patient categories. Later in 2024, the company will provide study findings on two patient groups: individuals ages 18 to 59 at high risk of severe RSV and those with impaired immune systems.

GSK is also reportedly working to increase the shot's international reach. Regulatory bodies in Europe, Japan, and other countries are examining GSK's request to broaden Arexvy's clearance to high-risk individuals ages 50 to 59.

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