GSK's RSV Vaccine Arexvy Gets Positive CHMP Opinion For Adults Aged 50-59 At Increased Risk

(RTTNews) - GSK plc (GSK, GSK.L) announced Monday that its Respiratory Syncytial Virus or RSV vaccine, Arexvy, has received positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP for adults aged 50-59 at increased risk for RSV disease.

The European Commission's final decision is expected by September 2024.

The CHMP has recommended expanding the approval of GSK's RSV vaccine for the prevention of lower respiratory tract disease or LRTD caused by RSV from adults aged 60 and above to include adults aged 50-59 years.

The company noted that the positive opinion, one of the final steps prior to the extension of the marketing authorisation by the European Commission, is the first time that an indication for adults aged 50-59 has been recommended by CHMP for a RSV vaccine.

The positive opinion is supported by results from a phase III trial evaluating the immune response and safety of GSK's RSV vaccine in adults aged 50-59, including those at increased risk for RSV-LRTD due to certain underlying medical conditions.

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 has approved GSK's RSV vaccine for adults aged 50-59 at increased risk.

GSK has also filed regulatory submissions to expand the use of its RSV vaccine to adults aged 50-59 at increased risk in Japan and other geographies with regulatory decisions undergoing review.

The company further noted 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 read out in the second half.

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