GSK plc GSK announced new data from the phase III AReSVi-006 (Adult Respiratory Syncytial Virus) study. The study evaluated the efficacy of a single dose of its respiratory syncytial virus (RSV) vaccine, Arexvy, for protection against lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older, including those who are at increased risk of the disease over three RSV seasons.
New data from the above mentioned study showed that treatment with a single dose of Arexvy cumulative efficacy over three full RSV seasons was clinically meaningful at 62.9% against RSV-LRTD and 67.4% against severe RSV-LRTD versus placebo.
Importantly, Arexvy demonstrated an efficacy of 48% against RSV-LRTD in the third season.
Per the company, Arexvy is the only RSV vaccine with efficacy and safety data available through three full RSV seasons. The vaccine’s safety and reactogenicity data were similar to that observed in previous phase III study data.
Arexvy Becomes an Important Revenue Driver for GSK
Arexvy is currently approved in the United States, Europe, Japan and several other countries for adults aged 60 and above for the prevention of LRTD caused by RSV.
Arexvy was approved for adults aged 50-59 years in the United States in June and in the EU in August 2024.
Regulatory applications seeking label expansion of Arexvy for adults aged 50-59 are also under review in Japan and some other countries. Clinical studies on Arexvy for expanded use in adults aged 18-49 are also ongoing, with data readouts expected later in 2024.
Arexvy was the first RSV vaccine for older adults to be approved anywhere in the world. It had an exceptional launch and generated £1.2 billion in sales in 2023. In the first six months of 2024, the vaccine generated £244 million in sales.
Arexvy’s lukewarm sales in the first half of 2024 were in line with anticipated seasonality patterns. Sales are likely to be much higher in the second half of the year.
Other Players in the RSV Vaccine Market
Pfizer’s PFE RSV vaccine, Abrysvo, was launched to help protect older adults as well as infants through maternal immunization in the United States as well as in the EU in 2023. Abrysvo recorded sales of $201 million in the first six months of 2024.
PFE is also evaluating Abrysvo in a phase III study for use in adults aged 18-59 years. Pfizer plans to seek approval from the FDA for the expanded use of Abrysvo for adults 18 years and older. However, the company has not yet provided any timeline for the filing.
Moderna MRNA has secured FDA approval for its mRNA-based RSV vaccine, mResvia, this May 2024. This vaccine is a new entrant in the RSV vaccine space. MRNA had already started shipping mResvia doses.
The EC granted marketing authorization to mRESVIA for use in adults aged 60 years and above in August.
Moderna is also evaluating its RSV vaccine in early-stage studies for high-risk adults, as well as maternal and pediatric populations.
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