2nd Mar 2023 07:00
(Alliance News) - 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’s RSV older adult vaccine candidate is also under regulatory review by the European Medicines Agency, Japan’s Ministry of Health, Labour and Welfare, and several other regulators, with decisions expected in 2023. Additional regulatory submissions are anticipated to continue throughout this year.
"Today's vote brings us an important step closer to delivering one of the world’s first vaccines for RSV, a respiratory virus that causes potentially debilitating disease and imposes a major burden on healthcare systems," said Global Head of Vaccines Research & Development Phil Dormitzer.
"Thousands of older adults in the US are impacted by RSV and those with underlying health conditions, like respiratory and heart diseases and diabetes, are at increased risk of severe complications. We're delighted that the Advisory Committee recognised the strength of our vaccine’s data and its potential to make a positive public health impact with a unanimous vote on the effectiveness of the vaccine."
Each year RSV causes over 470,000 hospitalisations and 33,000 deaths in adults in high-income countries, GSK said.
By Greg Rosenvinge, Alliance News reporter
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