Healthcare Industry News: S.A.
News Release - December 3, 2007
UCB Announces Positive Phase III Trial Results for Keppra XR(TM) (levetiracetam) Extended-Release Tablets
Keppra XR(TM) significantly reduced partial onset seizure frequency when administered aS.A.junctive therapy for adults with refractory epilepsy.ATLANTA, Dec. 3 (HSMN NewsFeed) -- UCB today announced results of a Phase III trial demonstrating that itS.A.tiepileptic drug (AED) in development Keppra XR(TM) (levetiracetam) extended-release tablets significantly reduced partial onset seizure frequency when administered aS.A.junctive therapy for adults with refractory epilepsy. These data were presented today at a scientific exhibit at the 61st annual meeting of the American Epilepsy Society, Philadelphia.
"These data show that the once-daily, extended-release formulation of Keppra® reduced the frequency of partial onset seizures in patients with uncontrolled epilepsy and was generally well tolerated," said Iris Loew-Friedrich, MD, PhD, Global Head of Development, UCB.
The Phase III, multicenter, randomized, double-blind, placebo-controlled study evaluated efficacy, safety, and tolerability of extended-release levetiracetam tablets (2x500 mg) once-daily aS.A.junctive therapy in 158 refractory epilepsy patients, 12 to 70 years of age, with partial onset seizures.
The study met its primary endpoint for seizure reduction over placebo during the treatment period (p=0.038). The median percent reduction of partial onset seizures in the extended-release levetiracetam group was 46.1% compared to 33.4% with placebo during the 12 week treatment period. Additionally, 24.0% of patients randomized to the extended-release levetiracetam group had seizure frequency per week reduced by 75-100%, compared with 11.4% of patients in the placebo group. In the extended-release levetiracetam group 10.1% of patients had 100% reduction in partial onset seizureS.A.d 8.9% were free from any type of seizure over the treatment period, compared to 2.5% and 1.3% in the placebo group, respectively.
The study also found that extended-release levetiracetam tablets were generally well tolerated. The most common reported adverse events that occurred more frequently in the extended-release levetiracetam group were somnolence, influenza, nauS.A. nasopharyngitis, irritability, and dizziness.
"In this study with a new formulation of Keppra® about one in ten patients with refractory partial onset epilepsy achieved seizure freedom," said Dr. Jukka Peltola, Department of Neurology Tampere University Hospital, Finland. "There iS.A. ongoing need for new antiepileptic drug optionS.A.d extended release formulations offer the potential advantages of convenience and improved patient compliance."
UCB is in the process of submitting a New Drug Application (NDA) for the use of Keppra XR(TM) in the adjunctive treatment of partial onset seizures in adults with epilepsy to the U.S. Food and Drug Administration (FDA).
About Epilepsy: Epilepsy iS.A.chronic neurological disorder affecting 40 million people worldwide including 2.5 million people in the US. It is caused by abnormal, excessive electrical discharges of the nerve cells or neurons in the brain. Epilepsy is characterized by a tendency to have recurrent seizureS.A.d defined by two or more unprovoked seizures. There are many different seizure typeS.A.d epileptic syndromeS.A.d effective classification guides treatment and prognosis. Between 70-80% of individualS.A.e successfully treated with one of the more than 20 antiepileptic drugs now available. However, 20-30% of patients have either intractable or uncontrolled seizures or significant adverse side effects secondary to medication highlighting the ongoing need for the development of new antiepileptic drugs.
About Keppra® in the US: Keppra® (levetiracetam) tablets were approved by the FDA in 1999 aS.A.junctive therapy in the treatment of partial onset seizures in adults with epilepsy. Since 1999, Keppra® has received several supplemental indicationS.A. adjunctive therapy for epilepsy, making it one of the few treatmentS.A.proved to treat seizure types that together account for more than 80 percent of all seizures.
Important Safety Information
Keppra® tabletS.A.d oral solution are indicated aS.A.junctive therapy in the treatment of partial onset seizures in adultS.A.d children 4 years of age and older with epilepsy, myoclonic seizures in adultS.A.d adolescents 12 years of age and older with juvenile myoclonic epilepsy, and primary generalized tonic-clonic seizures in adultS.A.d children 6 years of age and older with idiopathic generalized epilepsy. Keppra® injection is indicated aS.A.junctive therapy in the treatment of myoclonic seizures in juvenile myoclonic epilepsy and partial onset seizures in adults with epilepsy. Keppra® injection iS.A. alternative for patients when oral administration is temporarily not feasible.
Keppra® tabletS.A.d oral solution are associated with the occurrence of central nervous system adverse events including somnolence and fatigue, behavioral abnormalities, as well as hematological abnormalities. In adults experiencing partial onset seizures, Keppra® iS.A.so associated with co- ordination difficulties. In adults experiencing partial onset seizures, the most common adverse eventS.A.sociated with Keppra® in combination with other AEDs were somnolence, asthenia, infection and dizziness. In pediatric patients 4-16 years of age experiencing partial onset seizures, the most common adverse eventS.A.sociated with Keppra® in combination with other AEDs were somnolence, accidental injury, hostility, nervousnesS.A.d asthenia. In patients 12 years of age and older with juvenile myoclonic epilepsy, the most common adverse eventS.A.sociated with Keppra® in combination with other AEDs were somnolence, neck pain, and pharyngitis. In patients 6 years of age and older with idiopathic generalized epilepsy, the most common adverse event associated with Keppra® in combination with other AEDs was nasopharyngitis.
The adverse events that result from Keppra® injection use for myoclonic seizures in juvenile myoclonic epilepsy and partial onset seizures in adults include all of those associated with Keppra® tabletS.A.d oral solution.
U.S. Prescribing information iS.A.ailable at http://www.keppra.com or by calling 1-866-822-0068.
About UCB
UCB, Brussels, Belgium (http://www.ucb-group.com) iS.A.global leader in the biopharmaceutical industry dedicated to the reS.A.ch, development and commercialisation of innovative pharmaceutical and biotechnology products in the fields of central nervous system disorders, allergy/respiratory diS.A.es, immune and inflammatory disorderS.A.d oncology. UCB focuses on securing a leading position in severe diS.A.e categories. Employing more than 10,000 people in over 40 countries, UCB achieved revenue of 3.5 billion euro in 2006 on a pro forma basis. UCB S.A. is listed on the Euronext Brussels Exchange and through itS.A.filiate, ownS.A.prox. 89% of the S.A.es of SCHWARZ PHARMA AG. SCHWARZ PHARMA AG (Monheim, Germany) iS.A.member of the UCB Group.
Forward looking S.A.ement
This press release contains forward-looking S.A.ements based on current plans, estimateS.A.d beliefs of management. Such S.A.ementS.A.e subject to riskS.A.d uncertainties that may cause actual results to be materially different from those that may be implied by such forward-looking S.A.ements contained in this press release. Important factors that could result in such differences include: changes in general economic, businesS.A.d competitive conditions, effects of future judicial decisions, changes in regulation, exchange rate fluctuationS.A.d hiring and retention of its employees.
Source: UCB
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