The company have now advised that have withdrawn their marketing authorisation application from the European Medicines Authority (EMA) for this indication at this time. Therefore, this appraisal will remain suspended. As this appraisal has been referred to NICE we will continue to monitor any development and will update interested parties if the situation changes. For more information, please see the EMA website: http://www.ema.europa.eu/docs/en_GB/document_library/Medicine_QA/2018/02/WC500244301.pdf