UCB Announces FDA Filing for lacosamide in the Treatment of Partial Onset Seizures...
UCB Announces FDA Filing for lacosamide in the Treatment of Partial OnsetSeizures in Adults with EpilepsyU.S. Food and Drug Administration (FDA) has accepted for filing the New DrugApplication (NDA) for the use of lacosamide as adjunctive therapy in thetreatment of partial onset seizures in adults with epilepsy.ATLANTA, Nov. 29 /PRNewswire/ -- UCB announced today that the U.S. Foodand Drug Administration has accepted for filing the New Drug Application (NDA)for the use of lacosamide as adjunctive therapy in the treatment of partialonset seizures in adults with epilepsy. The application includes threelacosamide formulations -- tablets, syrup and an intravenous injection. Theproposed trade name for lacosamide is Vimpat(TM).
"This filing is another step in support of UCB's epilepsy franchise andits long-term commitment to advancing treatment options for patients withepilepsy," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB.
The NDA for lacosamide in epilepsy is supported by data from threeclinical trials with a total of approximately 1,300 adults with uncontrolledpartial onset seizures, despite taking one to three antiepileptic drugs
(AEDs). In these studies, significantly greater 50% responder rates andreductions in median seizure frequency were seen versus placebo. The mostcommon adverse events of lacosamide (greater than or equal to 10%) reported inthese trials included dizziness, headache, nausea and diplopia.
A similar filing made to the European Medicines Agency (EMEA) earlier thisyear for the use of lacosamide as adjunctive therapy in the treatment ofpartial onset seizures in adults with epilepsy, was accepted and is currentlyunder review.
About Epilepsy: Epilepsy is a chronic neurological disorder affecting 40million people worldwide including 2.5 million people in the US. It is causedby abnormal, excessive electrical discharges of the nerve cells or neurons inthe brain. Epilepsy is characterized by a tendency to have recurrent seizuresand defined by two or more unprovoked seizures. There are many differentseizure types and epileptic syndromes and effective classification guidestreatment and prognosis. Between 70-80% of individuals are successfullytreated with one of the more than 20 antiepileptic drugs now available.However, 20-30% of patients have either intractable or uncontrolled seizuresor significant adverse side effects secondary to medication highlighting theongoing need for the development of new antiepileptic drugs.
About Lacosamide: Lacosamide has a novel and dual mode of action. Itselectively enhances slow inactivation of sodium channels and interacts withthe neuroplasticity-relevant target-collapsin-response mediator protein-2
(CRMP-2).
About UCB
UCB, Brussels, Belgium (www.ucb-group.com) is a global leader in thebiopharmaceutical industry dedicated to the research, development andcommercialisation of innovative pharmaceutical and biotechnology products inthe fields of central nervous system disorders, allergy/respiratory diseases,immune and inflammatory disorders and oncology. UCB focuses on securing aleading position in severe disease categories. Employing more than 10,000people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchangeand, through its affiliate, owns approx. 89% of the shares of SCHWARZ PHARMAAG. SCHWARZ PHARMA (Monheim, Germany) is a member of the UCB Group.
Forward looking statement
This press release contains forward-looking statements based on currentplans, estimates and beliefs of management. Such statements are subject torisks and uncertainties that may cause actual results to be materiallydifferent from those that may be implied by such forward-looking statementscontained in this press release. Important factors that could result in suchdifferences include: changes in general economic, business and competitiveconditions, effects of future judicial decisions, changes in regulation,exchange rate fluctuations and hiring and retention of its employees.SOURCE UCB, IncAndrea Levin, Public Relations Manager of UCB, Inc, +1-770-970-8352, or+1-404-483-7329, Andrea.levin@ucb-group.com; or Lindsey Smith of ChandlerChicco Agency for UCB, Inc, +1-212-229-8481, or +1-914-720-4258,lsmith@ccapr.com
