Regulatory update: Trametinib US PDUFA date extended to 3 September 2013

Issued: London UK

GSK today announced that the US Prescription Drug User Fee Act (PDUFA) goal date for trametinib, its MEK inhibitor, has been extended by 3 months to 3 September 2013.  The company recently submitted additional manufacturing data to the Food and Drug Administration (FDA) and the extension to the original PDUFA goal date is to allow sufficient time for FDA to review the submission.

On 3 August 2012, GSK announced submission of a New Drug Application for trametinib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations as detected by an FDA-approved test.

On 7 February 2013, GSK announced submission of a Marketing Authorisation Application to the European Medicines Agency (EMA) for trametinib monotherapy and in combination with dabrafenib as a treatment for patients with unresectable or metastatic melanoma with BRAF V600 mutations.  The new manufacturing information submitted to FDA will also be shared with the EMA according to the standard centralised review process.

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.

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.