On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience (betrixaban), intended for the prevention of venous thromboembolism in acutely ill medical patients. Consequently the first appraisal committee discussion of this topic has been cancelled and NICE have suspended the appraisal. We will continue to monitor any developments and will update interested parties if the situation changes.
 
Status Suspended
Process STA pre-2018
ID number 913

Project Team

Project lead Thomas Feist

Email enquiries

Evidence Review Group / Assessment Group BMJ Evidence Centre, BMJ Group

Timeline

Key events during the development of the guidance:

Date Update
17 December 2018 On 26 July 2018, the Committee for Medicinal Products for Human Use (CHMP) re-examined the opinion and confirmed the refusal of the marketing authorisation. Therefore this topic will remain indefinitely suspended on the NICE work programme.
09 April 2018 Suspended, On 22 March 2018, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorisation for the medicinal product Dexxience (betrixaban), intended for the prevention of venous thromboembolism in acutely ill medical patients. Consequently the first appraisal committee discussion of this topic has been cancelled and NICE have suspended the appraisal. We will continue to monitor any developments and will update interested parties if the situation changes.
19 March 2018 Following a regulatory update from the company we will not be proceeding with the committee discussion scheduled for 17 April 2018. We will provide a further update when more information is available.
03 November 2017 Invitation to participate
25 January 2017 Draft scope documents
05 December 2016 Referral

For further information on how we develop guidance, please see our page about NICE technology appraisal guidance