CHMP reverses opinion, recommends approval for Vedrop
This article was originally published in Scrip
Executive Summary
The CHMP has reversed its opinion on Orphan Europe's Vedrop (tocofersolan), opting to recommend the drug as a treatment for vitamin E deficiency due to digestive malabsorption in paediatric patients suffering from congenital chronic cholestasis or hereditary chronic cholestasis. Although the committee issued a negative opinion on this drug earlier this year (scripnews.com, January 6th, 2009), it now recommends granting marketing authorisation under exceptional circumstances.