CHMP rejects Orphan Europe's vitamin E substitute
This article was originally published in Scrip
Executive Summary
The EU's CHMP has recommended refusing Orphan Europe's (Recordati) marketing authorisation for Vedrop (tocofersolan) 50mg/ml oral solution, which was intended for treatment of vitamin E deficiency in children with cystic fibrosis, or with congenital or hereditary chronic cholestasis. The CHMP cited a lack of data and insufficient evidence of its efficacy in cystic fibrosis patients.