GSK provides update on regulatory filings for Zunrisa/Rezonic

Issued: Monday 28 September 2009, London UK

GlaxoSmithKline (GSK) has made the difficult decision to discontinue the regulatory filings for Zunrisa/Rezonic (casopitant), which was being developed for chemotherapy-induced and post-operative nausea and vomiting. Regulatory applications were filed in a number of countries worldwide and GSK is currently communicating with those authorities and all study investigators.

GSK has made this decision, after regulatory consultation, based on the company’s assessment that significant further safety data would be required to support the registration of casopitant on a worldwide basis, which would take a considerable time to produce. Consequently, all on-going regulatory files for casopitant are being withdrawn.

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