Xyrem sodium oxybate regulatory update

UCB Group (Euronext:UCB, Brussels, Belgium) said EMA's CHMP issued a negative opinion recommending against the approval of an MAA for Xyrem sodium oxybate to treat fibromyalgia. UCB expects a decision on the MAA this half. Xyrem is already approved in Europe to treat excessive daytime sleepiness and cataplexy in patients with narcolepsy. UCB has ex-North American commercialization rights to the oral liquid formulation of the sodium salt of gamma hydroxybutyrate (GHB) for fibromyalgia from Jazz. ...