On 18 April 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 Alsitek (masitinib), intended for the treatment of amyotrophic lateral sclerosis (ALS). The appraisal will therefore remain suspended and we will continue to monitor any developments and will update interested parties if the situation changes.
 
Status Suspended
Process STA pre-2018
ID number 967

Project Team

Project lead Thomas Feist

Email enquiries

Timeline

Key events during the development of the guidance:

Date Update
09 May 2018 Suspended, On 18 April 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 Alsitek (masitinib), intended for the treatment of amyotrophic lateral sclerosis (ALS). The appraisal will therefore remain suspended and we will continue to monitor any developments and will update interested parties if the situation changes.
23 February 2018 Suspended: The company has been unable to provide a submission for this appraisal within the required timelines. Therefore the appraisal will be put on hold and the committee meeting scheduled for 22 May 2018 will not take place. We will update you on any developments as soon as possible.
29 September 2017 As you will be aware, the Department of Health has asked NICE to conduct an appraisal of masitinib for treating amyotrophic lateral sclerosis. Please note that following on from advice received from the company this appraisal has been rescheduled to align with latest regulatory expectations. Therefore, the deadline for submissions is now expected to be early February 2018.
04 August 2017 Invitation to participate
27 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