GSK's Respiratory Syncytial Virus Older Adult Vaccine Candidate Gets Positive CHMP Opinion

(RTTNews) - GSK plc (GSK, GSK.L) said that the European Medicines Agency's Committee for Medicinal Products for Human Use or CHMP has adopted a positive opinion by consensus recommending approval of GSK's respiratory syncytial virus or RSV vaccine candidate for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older.

GSK's marketing authorisation application has been reviewed under accelerated assessment. This applies to products determined by the CHMP to be of major interest for public health and therapeutic innovation. The European Commission's final decision is expected by July 2023.

GSK said that its RSV older adult vaccine candidate is also under regulatory review by the US Food and Drug Administration, Japan's Ministry of Health, Labour and Welfare, and several other regulatory agencies, with decisions expected in 2023. Additional regulatory submissions will continue throughout this year.

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