Regulatory Update: GSK announces submissions for two influenza vaccines
GlaxoSmithKline [GSK] announced today that it has submitted regulatory files for two of its influenza vaccines currently in development.
- (1888PressRelease) March 06, 2012 - Quadrivalent influenza vaccine
GSK has submitted US and EU regulatory applications seeking approval of a quadrivalent influenza vaccine for the “active immunisation of adults and children from 3 years of age for the prevention of influenza disease caused by influenza virus types A and B contained in the vaccine”.
A supplemental Biologics License Application has been submitted to the U.S. Food and Drug Administration (FDA) and a new application has been submitted to European regulatory authorities. The quadrivalent influenza vaccine is currently not approved or licensed anywhere in the world for the prevention of influenza.
H5N1 influenza vaccine
A regulatory application has also been submitted to the U.S. FDA seeking approval for an H5N1 influenza vaccine.
The Biologics License Application seeks approval for the “active immunisation for the prevention of disease in persons 18 years of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine” for use as directed by the U.S. Government.
GSK’s H5N1 pandemic influenza vaccine, manufactured in Quebec, is currently approved in Europe under the brand name, Pumarix™. For more information about the currently licensed indication of Pumarix™ in Europe,
please visit the EMA website.
The H5N1 influenza vaccine programme was supported by a development contract (HHSO100200700029C) with the Biomedical Advanced Development and Research Authority (BARDA) of the US 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 www.gsk.com
GlaxoSmithKline Biologicals - (GSK Biologicals), GlaxoSmithKline’s vaccines business, is one of the world’s leading vaccine companies and a leader in innovation. The company is active in vaccine research,
development and production with over 30 vaccines approved for marketing and 20 more in development - both in the prophylactic and therapeutic fields. Headquartered in Belgium, GSK Biologicals has 14 manufacturing sites strategically positioned around the globe. In 2010, GSK Biologicals distributed 1.43 billion doses of vaccines to 179 countries in both the developed and the developing world.
Through its accomplished and dedicated workforce, GSK Biologicals applies its expertise to the discovery of innovative vaccines that contribute to the health and well-being of people of all generations around the world.
GlaxoSmithKline 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 'Business Review' in the company's Annual Report on Form 20-F for 2010.
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