CHMP rejects Orphan Europe's vitamin E substitute
This article was originally published in Scrip
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.
You may also be interested in...
Somaxon Pharmaceuticals and Procter & Gamble Pharmaceuticals are to co-promote Somaxon's insomnia drug Silenor (low-dose doxepin) in the US.
GlaxoSmithKline has begun the Phase III clinical trials programme for its adjuvanted vaccine candidate (GSK1437173A) against herpes zoster for the prevention of shingles.
The EMA has accepted Optimer Pharmaceuticals' MAA for its narrow-spectrum antibiotic fidaxomicin for the treatment of Clostridium difficile infection (CDI) and for the prevention of recurrences of CDI.