![]() Vice President Corporate Communication & Investor RelationsĮmail The U.S. UCB is listed on Euronext Brussels (UCB / UCBBt.BR / UCB BB). UCB employs over 8,500 people operating in over 40 countries. UCB key products are Keppra ® (antiepileptic), Xyzal ® and Zyrtec ® (antiallergics), Nootropil ® (cerebral function regulator), Tussionex ® (antitussive) and Metadate(TM) / Equasym XL(TM) (attention deficit/hyperactivity disorder). UCB ( is a global biopharmaceutical leader with headquarters in Brussels, Belgium, specialising in the fields of central nervous system disorders, inflammatory diseases, and oncology. Ī follow-up, 12-month open-label study showed that Xyrem® (3-9 g) was well-tolerated and produced significant and long-term clinical improvement in the frequency of cataplexy attacks and diminished day-time sleepiness. Investigators assessed changes in disease severity using the Clinical Global Impression of change (CGI-c) measure, and Xyrem® (9 g) was found to significantly decrease the frequency of cataplexy attacks compared to placebo. Results of this four-week study showed that in comparison to placebo, Xyrem® demonstrated clinical improvements in the reported number of weekly cataplexy attacks and daytime sleepiness. Xyrem® was taken in divided nightly doses immediately before bed-time and repeated 2½-4 hours later. The European marketing approval of Xyrem® was mainly based on a prospective, multicentre, randomized, double-blind, placebo-controlled trial that examined the safety and efficacy of Xyrem® (3 g, 6 g and 9 g) for the treatment of narcolepsy symptoms. European orphan drug designation enables recipient sponsors to receive regulatory guidance in the drug development process and allows for up to 10 years of European market exclusivity for the designated indication upon approval of the market application. Orphan medicinal products are used to diagnose, prevent or treat life-threatening or very serious conditions that are rare, with a prevalence of less than five per 10,000 of the EU population. Xyrem® was designated as an orphan medicinal product on February 3, 2003. by Jazz Pharmaceuticals and has been available in the U.S. In Europe, the approval of Xyrem® for the treatment of cataplexy in patients with narcolepsy provides a welcome addition to the pharmacological armamentarium."ġ. UCB acquired the licence to distribute Xyrem® in Europe from Orphan Medical recently acquired by Jazz Pharmaceuticals). Thomas Hospital, London, UK said "Patients and physicians in the EU should be encouraged by the body of clinical research supporting Xyrem®. Ĭommenting on the marketing approval Adrian Williams MD of Sleep Centre, St. It involves a sudden reversible loss of muscle tone, usually triggered by emotional stimuli such as laughter, excitement, surprise and anger, with contributing factors including physical fatigue, stress or sleepiness. Cataplexy is a typical symptom of narcolepsy and is present in 65-70% of patients with narcolepsy. Narcolepsy is a debilitating, life-long neurological disorder that is characterised by excessive daytime sleepiness and sleep attacks. We are delighted to serve European physicians and sleep centres with a product that can help fulfil the unmet medical need in patients with this serious sleep disorder." said Emmanuel Caeymaex, Vice-President, Marketing CNS, UCB. "Xyrem® provides physicians and patients in Europe with the first and only EMEA approved medication for the treatment of cataplexy in patients with narcolepsy. Launch in this first major European market follows the recent European Commission (EC) marketing approval of Xyrem® in this orphan indication, with pan-European commercialisation expected over 2006. Cimzia® - Axial spondyloarthritis (axSpA)īrussels, Belgium - December 8, 2005: UCB announced today that Xyrem® (sodium oxybate) oral solution is now available in Germany for the treatment of cataplexy in adult patients with narcolepsy.Registration and Results Reporting on Public Registries.Plain Language Summaries of research results.Access to Patient-Level Clinical Study Data.Plain language summaries of study results.Hydrocodone bitartrate extended release (HC-ER). ![]() ![]() Hydrocodone Bitartrate controlled release (HC-CR).Ferrous(II) glycine sulphate complex (Ferro Sanol®).Clinical studies at UCB: How are medicines made and tested?.Disclosure of payments to Healthcare Professionals.
0 Comments
Leave a Reply. |