Alsitek

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masitinib

Refused
This medicine was refused authorisation for use in the European Union.

Overview

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.

This EPAR was last updated on 31/07/2018

Application details

Product details
Name
Alsitek
Active substance
masitinib mesylate
International non-proprietary name (INN) or common name
masitinib
Therapeutic area (MeSH)
Amyotrophic Lateral Sclerosis
Anatomical therapeutic chemical (ATC) code
L01XE22
Orphan

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

Application details
Marketing-autorisation applicant
AB Science
Date of opinion
19/04/2018
Date of refusal of marketing authorisation
25/07/2018

Assessment history

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