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GSK PLC on Wednesday said the US Food & Drug Administration’s advisory committee voted to support its respiratory syncytial virus vaccine candidate for older adults. The Brentford, London-based pharmaceutical company said this was ahead of expected decision on US approval by May 3 for the vaccine candidate that aims to prevent lower respiratory tract disease caused by RSV in adults aged 60 years and older. The Vaccines & Related Biological Products Advisory Committee voted unanimously that the data support the effectiveness of the vaccine, and by 10 to 2 that the data support the safety of the vaccine. GSK said the evidence reviewed by the committee was supported by ‘pivotal’ data from the AReSVi-006 phase 3 trial, recently published in the New England Journal of Medicine. In November 2022, the FDA accepted the biologics license application for GSK’s RSV older adult vaccine candidate under priority review and assigned a Prescription Drug User Fee Act action date of May 3. GSK‘
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