News out - EMA COMP minutes
Minutes from the COMP meeting with positive opinion for approval by EMA
13 May 2015
EMA/COMP/209468/2015
Procedure Management and Committees Support Division Committee for Orphan Medicinal Products (COMP)
Minutes of the 14-16 April 2015 meeting
2.2.3 5,7-Dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride for treatment of Huntington’s disease, Prana Biotechnology UK Limited -EMA/OD/017/15[COMP co-ordinator: A. Andric]
The Committee agreed that the condition, Huntington’s disease, is a distinct medical entity and meets the criteria for orphan designation. The intention to treat the condition with the medicinal product containing 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride was considered justified based on pre-clinical in vivo data and preliminary clinical data showing improvement in parameters associated with the condition. The condition is life-threatening and chronically debilitating due to severe behavioural and cognitive disturbances, progressive motor dysfunction and potentially fatal complications. The condition was estimated to be affecting approximately 1 in 10,000 persons in the European Union, at the time the application was made. In addition, although satisfactory methods of treatment of the condition have been authorised in the European Union, the sponsor has provided sufficient justification for the assumption that the medicinal product containing 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride may be of significant benefit to those affected by the condition. The sponsor has provided preliminary clinical data that demonstrate an improvement in a relevant parameter when the product is used in combination with tetrabenazine. The Committee considered that this
could constitute a clinically relevant advantage. A positive opinion for containing 5,7-dichloro-2-dimethylaminomethyl-8-hydroxyquinoline hydrochloride, for treatment of Huntington’s disease, was adopted by consensus.
The sponsor has provided preliminary clinical data that demonstrate an improvement in a relevant parameter when the product is used in combination with tetrabenazine. The Committee considered that this could constitute a clinically relevant advantage. "
Wonder which relevant parameter that was that caused the "clinically relevant advantage?" To me this indicates that a team of experts agree PBT2 may be disease modifying. Huge!
