GSK Announces EU Approval of Arexvy, the First RSV Vaccine for Adults Aged 60 and Older

Jun 07, 2023 15:39 CST Updated 15:39

GSK

Pharmaceutical R&D Manufacturer

European Commission

The European Commission, abbreviated as the EU Commission, is a supranational body under the European Union. Within the EU political system, the European Commission primarily undertakes executive tasks, thus being roughly equivalent to the government in a national system. However, the European Commission has other functions as well. In particular, except for the few circumstances specified in the treaties, the European Commission is the only institution with legislative power in the EU legislative process.

Intelligent Finance APP learned that GlaxoSmithKline (GSK.US), a global leader in biopharmaceuticals and consumer healthcare, announced on Wednesday local time that its world-first respiratory syncytial virus (RSV) vaccine Arexvy has been approved by the European Commission for use in adults aged 60 years or older. The EU granted this authorization based on Phase III efficacy data. In the trial, the overall efficacy of the vaccine was 82.6%, achieving the primary endpoint in adults aged 60 years or older with statistical and clinical significance.

The vaccine is planned to be launched in the 2023/2024 RSV outbreak season, which typically begins in the fall. GSK stated in a press release: "RSV is a common contagious respiratory virus, with over 270,000 people hospitalized annually in Europe and approximately 20,000 adults aged 60 and above dying in hospitals."

Many of these elderly patients suffer from underlying conditions such as diabetes and chronic cardiopulmonary diseases, leading to the majority requiring hospitalization. It is estimated that approximately 3 million cases are reported annually in this age group.

On Tuesday, GSK's share price closed at 1,391.40 pence on the London Stock Exchange, up 0.68% or 9.40 pence. As of the close on Tuesday, GSK rose nearly 1% to $34.62 in the US stock market.