GSK Share Price Rose 0.89% as the EMA Reviews Its RSV Drug

The GSK plc (LON: GSK) share price rose 0.89% after announcing that its respiratory syncytial virus (RSV) vaccine, Arexvy, has been submitted for review by the European Medicines Agency (EMA) for use in preventing RSV in adults aged 50-59 who have a higher risk of contracting the disease.

This submission is backed by encouraging outcomes from a Phase III clinical trial, demonstrating a robust immune response and satisfactory safety profile in this age group. Adults over 50, especially those with certain health conditions, are more susceptible to RSV.

GSK is pioneering efforts to seek regulatory approval for extending RSV vaccination to adults in the 50-59 age bracket at higher risk due to underlying health issues.

Arexvy, currently approved in Europe for adults aged 60 and older to prevent lower respiratory tract disease (LRTD) caused by RSV, could become the first vaccine to offer protection to the 50-59 age group if approved.

The phase III trial (NCT05590403) assessed the vaccine's effectiveness and safety in adults aged 50-59, including those at heightened risk of severe RSV-related LRTD due to pre-existing medical conditions.

RSV's impact on adults is often underestimated, partly due to limited awareness, inconsistent testing, and under-reporting in studies. People with chronic diseases like COPD, asthma, heart failure, and diabetes are more prone to severe RSV infections. RSV can worsen these conditions and may lead to pneumonia, hospitalisation, or even death. 

The risk profile for adults aged 50-59 at increased risk is comparable to those aged 60 and above. The European regulatory decision on this application is expected in the third quarter of 2024.

GSK's RSV vaccine is an adjuvanted recombinant vaccine containing the RSVPreF3 glycoprotein combined with GSK's proprietary AS01E adjuvant. The EMA has already approved this vaccine for preventing RSV-caused LRTD in individuals aged 60 and above. 

The vaccine has also received approval in the US, Japan, the UK, Canada, and several other countries for the same age group. Reviews for further approvals are ongoing, and the proposed trade name is pending regulatory acceptance in other regions.

The AS01 adjuvant system used in the vaccine includes the STIMULON QS-21 adjuvant, licensed from Antigenics Inc., a subsidiary of Agenus Inc.

GSK share price. 

The GSK share price rose 0.89% to trade at 1552.90p from Friday’s closing price of 1539.20p.