GlaxoSmithKline announces vote from FDA advisory committee to recommend approval of H5N1 influenza vaccine candidate.
Issued: Wednesday 14 November 2012, London UK
GlaxoSmithKline plc (GSK) announced today that the U.S. Food and Drug Administration's (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine candidate supports its licensure for the active immunisation for the prevention of disease in persons 18 years of age and older who are at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
"GSK has been collaborating with the U.S. Department of Health and Human Services since 2006 to develop this H5N1 vaccine and we are pleased with the positive vote recommending its approval" commented Bruce Innis, Vice President, GSK Global Vaccines Discovery and Development. "We now look forward to a final decision by the FDA later this year and to also continuing our collaboration with the U.S. Government on public health issues".
The VRBPAC provides the FDA with independent expert advice and non-binding recommendations for consideration by the FDA, with the final decision on approval made by the FDA. According to agency regulations, the FDA is scheduled to conclude its review for the vaccine in December 2012. If approved, the vaccine is to be used only according to official guidance from the U.S. Government.
About H5N1 Influenza Vaccine Candidate
The H5N1 influenza vaccine candidate, manufactured in Québec, is a two-component vaccine consisting of a monovalent, inactivated, split A/H5N1 influenza virus antigen and the AS03 adjuvant system. In clinical trials, the most common solicited local reactions and general adverse events were injection site pain and swelling, muscle aches, headache, fatigue, joint pain, shivering and sweating. The regulatory filing was previously announced in March 2012.
GSK's H5N1 influenza vaccine manufactured in Québec is currently approved in Europe under the brand name, Pumarix™. For more information about the currently licensed indication of Pumarix™ in Europe, please visit http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/001212/human_med_
001412.jsp&mid=WC0b01ac058001d124.
The H5N1 influenza vaccine programme was supported by a development contract (HHSO100200700029C) with the Biomedical Advanced Development and Research Authority (BARDA) of the U.S. Department of Health and Human Services.
GlaxoSmithKline – one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit http://www.gsk.com/
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Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk factors' in the 'Financial review & risk' section in the company's Annual Report 2011 included as exhibit 15.2 to the company's Annual Report on Form 20-F for 2011.