US FDA grants GSK RSV vax label expansion

Arexvy received the first US FDA approval for RSV in May 2023 for the prevention of lower respiratory tract disease (LRTD). The authorization approved use for Arexvy in individuals 60 years of age and older, but GSK said it hoped to bring the vaccine to a wider patient population.

Now, GSK’s goal has been attained, with the authorization body expanding Arexvy’s label for use in adults in the US who are 50-59 years old if they have a medical condition that increases their risk of severe RSV effects.

The firm said the regulatory application was backed by positive results from its Phase III trial (NCT05590403). The study investigated the immune response and safety of Arexvy in adults aged 50-59 and included individuals who are risk of RSV-LRTD due to various other medical conditions, such as asthma, diabetes, heart failure, and chronic obstructive pulmonary disease (COPD).

“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,” said Tony Wood, chief scientific officer, GSK.

The company said it has also filed regulatory submissions to expand the use of Arvexy to adults aged 50-59 at increased risk in Japan, Europe, and other geographies that were not disclosed. The regulatory decisions for the other countries are undergoing review and GSK will continue its clinical development program to assess the safety and immunogenicity in adults 18 and over with data anticipated in the second half of this year.

“I am thrilled that GSK’s RSV vaccine is now approved for adults aged 50-59 at increased risk of RSV-LRTD. When it comes to the risks associated with RSV, age is just a number, an important number, but not the only factor to consider. Many adults in this age group have underlying health conditions that place them at increased risk for serious illness with RSV infection compared with those without these conditions. Now there is a vaccine approved that can help protect them,” Ann Falsey, University of Rochester School of Medicine, commented.