GSK’s £1.2bn Arexvy vaccine wins FDA approval for younger age range

Pharmaceutical giant GSK has won a key part of the regulatory approval needed to roll out its vaccine for respiratory syncytial virus (RSV) to adults aged 50 to 59.

The US Food and Drug Administration (FDA) gave the go-ahead for expansion of the use of the drug, called Arexvy, which is already allowed for people aged 60 and older.

RSV typically causes cold-like symptoms, and leads to 177,000 hospital admissions and 14,000 deaths a year in the US.

The approval marks a key milestone for GSK, which already dominates the market for drugs that treat RSV, taking a two-thirds market share in the first quarter.

It makes Arexvy the first vaccine endorsed for the under-60s by the FDA, ahead of rivals made by Pfizer and Moderna. The drug hit the market last year.

However, GSK will need to wait to see if the US Centres for Disease Control and Prevention signs off on the expanded use when it meets later this month before rolling it out.

The approval comes at a tricky time for GSK, which has seen shares plummet 9% in the last month after a US judge allowed more than 70,000 lawsuits against its discontinued heartburn drug Zantac to go forward.

Arexvy brought in about £1.2 billion in sales last year, beating the 890 million US dollars (£699 million) in revenue that Pfizer’s rival drug generated.

GSK said more than 13 million adults have a medical condition that increases their risk of severe RSV outcomes.

Chief scientific officer Tony Wood said: “Today’s approval reflects the importance of broadening the benefits of RSV immunisation to adults aged 50-59 who are at increased risk.

“For those with underlying medical conditions, RSV can have serious consequences, so we are proud to be the first to help protect them from RSV-LRTD.”