GSK plc (GSK, GSK.L) announced that its Respiratory Syncytial Virus (RSV) vaccine, Arexvy, has received a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) for adults aged 50-59 who are at an increased risk for RSV disease.
The European Commission's final decision on this matter is anticipated by September 2024.
The CHMP has advised extending the approval of GSK's RSV vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV, which currently covers adults aged 60 and above, to now include adults aged 50-59 years.
This positive opinion marks the first occasion that the CHMP has recommended an RSV vaccine for adults aged 50-59. The recommendation is supported by results from a phase III trial that assessed the immune response and safety of GSK's RSV vaccine in adults aged 50-59, particularly those with underlying medical conditions that increase their risk for RSV-LRTD.
Since June 2023, Arexvy (respiratory syncytial virus vaccine, recombinant, adjuvanted) has been approved in Europe for adults aged 60 and over for the prevention of RSV-LRTD.
In early June, the U.S. Food and Drug Administration (FDA) also approved GSK's RSV vaccine for adults aged 50-59 at increased risk.
GSK has additionally made regulatory submissions to expand the use of its RSV vaccine to adults aged 50-59 at increased risk in Japan and other regions, with decisions currently under review.
Furthermore, GSK indicated that trials evaluating the immunogenicity and safety of the vaccine in adults aged 18-49 at increased risk due to certain underlying medical conditions and in immunocompromised adults aged 18 and over are expected to yield results in the second half of the year.
