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, intended for the treatment of amyotrophic lateral sclerosis (ALS).
The company that applied for authorisation is AB Science. It had requested a re-examination of the opinion but later withdrew its request.
Questions and answers on refusal of the marketing authorisation for Alsitek (masitinib) (PDF/91.89 KB)Adopted
First published: 20/04/2018
Last updated: 01/06/2018
EMA/207380/2018 Rev. 2
|International non-proprietary name (INN) or common name||
|Therapeutic area (MeSH)||
Amyotrophic Lateral Sclerosis
|Anatomical therapeutic chemical (ATC) code||
This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.
|Date of opinion||
|Date of refusal of marketing authorisation||