Regulatory update: GlaxoSmithKline receives complete response from FDA for candidate pandemic H5N1 adjuvanted influenza vaccine
Issued: 25 March, 2013, London UK
GlaxoSmithKline [NYSE:GSK] announced today that it has received a Complete Response letter from the U.S. Food and Drug Administration (FDA) in response to the Biologics License Application (BLA) for its Pandemic Influenza A Virus Monovalent Adjuvanted candidate vaccine, referred to as Q-Pan H5N1.
The candidate vaccine is intended for active immunization for the prevention of disease in adults 18 years of age and older who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.
A Complete Response letter is issued by FDA when a Prescription Drug User Fee Act (PDUFA) action date nears and additional review time is needed prior to approval. In this case, the Complete Response letter was triggered due to an administrative matter that has recently been rectified. GSK and the FDA are actively working together to complete the review in a timely manner.
GSK’s Pandemic H5N1 influenza vaccine programme is 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. In November 2012, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted unanimously 14-0 that the safety and immunogenicity data of the H5N1 adjuvanted influenza vaccine supports its licensure in adults.
About GSK Vaccines GlaxoSmithKline Vaccines is active in vaccine research and development. Headquartered in Belgium, GSK Vaccines has 13 manufacturing sites strategically positioned around the globe. Of the 883 million doses of our vaccines we distributed in 2012, over 80% went to developing countries, which include the least developed, low- and middle-income countries.
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 www.gsk.com.
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Cautionary statement regarding forward-looking statements 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 Item 3.D 'Risk factors' in the company's Annual Report on Form 20-F for 2012.
