March 17, 2011
CHMP declines to recommend UCB's Xyrem for fibromyalgia
Last Updated:March 17, 2011 17:40
UCB on Thursday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use did not recommend Xyrem (sodium oxybate) for approval as a treatment for fibromyalgia in adults. UCB Chief Medical Officer Iris Loew-Friedrich said "we are very disappointed with the CHMP decision given the significant unmet medical need in fibromyalgia syndrome in Europe," where no drugs have been approved to date for the condition.
Partner Jazz Pharmaceuticals in October received a complete response letter from the FDA regarding its application to market the drug under the name JZP-6. The agency requested that the company conduct further clinical trials, as well as provide further data on the product's safe use.
Xyrem is currently approved in both the US and EU as a treatment for narcolepsy.
Reference Articles
UCB Fails to Win EMA Backing for Xyrem Fibromyalgia Drug - (Bloomberg)
Xyrem not recommended for fibromyalgia syndrome in the EU - (UCB)
CHMP declines to recommend UCB's Xyrem for fibromyalgia
Last Updated:March 17, 2011 17:40
UCB on Thursday announced that the European Medicines Agency's Committee for Medicinal Products for Human Use did not recommend Xyrem (sodium oxybate) for approval as a treatment for fibromyalgia in adults. UCB Chief Medical Officer Iris Loew-Friedrich said "we are very disappointed with the CHMP decision given the significant unmet medical need in fibromyalgia syndrome in Europe," where no drugs have been approved to date for the condition.
Partner Jazz Pharmaceuticals in October received a complete response letter from the FDA regarding its application to market the drug under the name JZP-6. The agency requested that the company conduct further clinical trials, as well as provide further data on the product's safe use.
Xyrem is currently approved in both the US and EU as a treatment for narcolepsy.
Reference Articles
UCB Fails to Win EMA Backing for Xyrem Fibromyalgia Drug - (Bloomberg)
Xyrem not recommended for fibromyalgia syndrome in the EU - (UCB)