Regulatory update: albiglutide US PDUFA date extended by three months
Issued: Friday 2August 2013, London UK
GlaxoSmithKline plc (LSE:GSK) today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes, has been extended by three months to 15 April 2014 to provide time for a full review of information submitted by GSK in response to the Food and Drug Administration's requests.
GSK announced the submission of a Biologics Licence Application to the US FDA for albiglutide on 14 January 2013 and this was followed by the submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) on 7 March 2013. The EMA filing is progressing to schedule. Albiglutide is not approved for use anywhere in the world.
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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