Committee for Orphan Medicinal Products (COMP): Monthly report from the October 2011 meeting
Reference Number: EMA/COMP/811210/2011Summary:
The Committee for Orphan Medicinal Products held its 127th plenary meeting on 5-7 October 2011.
This month the COMP delivered for a first time ever a positive opinion on orphan designation for the treatment of Leigh syndrome, for which no authorised treatments exist in the EU. This syndrome is a very rare and severe disease caused by mutations in mitochondrial respiratory enzymes, leading mainly to neurological deficits and a poor survival for these patients.
Committee for Orphan Medicinal Products (COMP): Monthly report from the July 2011 meeting
Reference Number: EMA/COMP/399953/2011Summary:
The Committee for Orphan Medicinal Products held its 125th plenary meeting on 6-8 July 2011.
During this meeting the Committee agreed to support the initiative to publish the prevalence figures and information on their sources for conditions that have been subject of orphan designations. The initiative aims at increasing transparency on orphan designation and acknowledging the work done for the prevalence calculation in the context of designation, which can be helpful as initial reference for future applications.