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GSK plc (LSE/NYSE:GSK), a leading pharmaceutical company, announced today that the European Medicines Agency (EMA) has commenced the review process for the use of its adjuvanted recombinant respiratory syncytial virus (RSV) vaccine, Arexvy, in adults aged 18 and over. The vaccine, which is already approved for older adults, is expected to receive a regulatory decision in the first half of 2026.
RSV is a widespread virus that can lead to severe respiratory illness, hospitalizations, and fatalities, particularly in older adults and those with underlying health conditions. The EMA’s acceptance of the application to extend the use of Arexvy represents a significant step in broadening the vaccine’s reach to a wider adult population.
Arexvy was the first RSV vaccine to be approved in the European Economic Area for preventing lower respiratory tract disease caused by RSV in adults aged 60 and older and for those aged 50-59 at increased risk of RSV disease. The vaccine combines recombinant RSV glycoprotein F stabilized in the prefusion conformation with GSK’s proprietary AS01E adjuvant.
GSK continues to pursue expanded indications for Arexvy in other regions, including the United States and Japan. The vaccine is currently approved in over 60 countries for individuals 60 years of age and older and in more than 50 markets, including the US, Japan, and Europe, for adults aged 50-59 with certain medical conditions.
The company reminds healthcare professionals and vaccine recipients that the use of the vaccine should align with official recommendations. The updated product information for Arexvy, including important dosage, administration, and safety details, can be found on the EMA’s website.
The information in this article is based on a press release statement from GSK plc.
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