GSK says RSV jab gets EU recommendation, settles Zantac case

The FTSE 100 pharmaceuticals giant said the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) recommended the expansion of its Arexvy vaccine to adults aged 50 to 59 at increased risk for RSV disease, making it the first vaccine in the EU for such a demographic.

It said the European Commission is expected to make a final decision on the marketing authorisation by September.

Arexvy was already approved in Europe for adults aged 60 and above for the prevention of lower respiratory tract disease (LRTD) caused by RSV.

The CHMP's positive opinion was based on a phase three trial evaluating the immune response and safety of the vaccine in adults aged 50 to 59, particularly those with underlying medical conditions such as chronic obstructive pulmonary disease (COPD), asthma, heart failure, and diabetes.

GSK said such conditions heighten the risk of severe RSV outcomes, including pneumonia, hospitalisation, or death.

RSV causes around 270,000 hospitalisations and 20,000 in-hospital deaths in Europe annually among adults aged 60 and over.

The disease burden for adults aged 50 to 59 at increased risk was comparable to that of the older population, with the vaccine's expansion intended to address the critical need.

In addition to the European regulatory progress, GSK said its RSV vaccine was approved by the US FDA for adults aged 50 to 59 at increased risk in June.

Regulatory submissions had also been made in Japan and other regions, with decisions pending.

Furthermore, ongoing trials were evaluating the vaccine's immunogenicity and safety in adults aged 18 to 49 at increased risk and in immunocompromised adults aged 18 and over, with results expected in the second half of 2024.

Separately, GSK announced that it had settled a legal case with Ronald Kimbrow in Illinois state court, over its discontinued heartburn drug Zantac, or ranitidine.

The company said the confidential settlement resolved the case without it admitting any liability, with the case to be dismissed.

GSK noted that scientific consensus from 16 epidemiological studies indicated no consistent or reliable evidence linking ranitidine to an increased cancer risk.

The company said it remained committed to defending itself in related litigation and managing these matters in the best interests of its shareholders.

At 0819 BST, shares in GSK were up 0.45% at 1,560.5p.

Reporting by Josh White for Sharecast.com.