UCB receives CHMP positive opinion on Keppra® for infants and young
children with partial-onset epil
(Thomson Reuters ONE) - European marketing approval recommended for Keppra® (levetiracetam)as adjunctive treatment of partial-onset seizures in infants andyoung children aged one month to under four yearsBrussels (Belgium), 24th July, 2009 - press release - UCB announcedtoday that the Committee for Medicinal Products for Human Use (CHMP)of the European Medicines Agency (EMEA) has issued a positive opinionrecommending that the European Commission grant marketingauthorisation for Keppra® as adjunctive treatment of partial-onsetseizures in infants and young children aged one month to under fouryears.The CHMP decision is based on the results of a Phase III,double-blind, randomised, multi-centre, placebo-controlled studyevaluating the efficacy and tolerability of Keppra® oral solution(20-50 mg/kg/day) in 116 paediatric patients with refractorypartial-onset seizures, aged from one month to under four years.Infants and children in this study were experiencing partial-onsetseizures with or without secondary generalisation that wereinadequately controlled despite treatment with one or two otherantiepileptic drugs."This is the first well-controlled study providing information on theefficacy and tolerability of levetiracetam in infants and youngchildren with inadequately controlled partial-onset seizures. Theresults of this study suggest that levetiracetam will be a valuablenew treatment option in very young patients with partial-onsetepilepsy." said Associate Professor Jesus Eric Pina-Garza, Children'sHospital at Vanderbilt, Nashville, Tennessee, U.S.In this clinical trial Keppra® was shown to significantly reduce thefrequency of partial-onset seizures with 43.1% of Keppra®-treatedpatients experiencing at least a 50% reduction in seizure frequencyduring the evaluation period (five days) compared with 19.6% ofplacebo-treated patients (p=0.013). Keppra® was generallywell-tolerated in this paediatric population. The most commonlyreported treatment-emergent adverse events (>5%) that occurred morefrequently in the Keppra® group were somnolence (13.3% vs. 1.8% forplacebo) and irritability (11.7% vs. 0% for placebo)."For parents of very young children with partial-onset seizures thatare poorly controlled with their current medication, the CHMPpositive opinion is encouraging news. We look forward to the finaldetermination of the European Commission and extending theavailability of Keppra® as adjunctive therapy to children from onemonth to under four years with partial-onset seizures", said TroyCox, President, CNS Operations, UCB.Since its first launch in 1999, an innovative research and clinicaltrials programme has enabled Keppra® to realise its potential as abroad spectrum antiepileptic drug. As a result, it is available for arange of seizure types and in a range of formulations (250 mg, 500mg, 750 mg and 1 000 mg tablets, 100 mg/ml oral solution and 100mg/ml concentrate for solution for infusion, an alternative forpatients when oral administration is temporarily not feasible.In Europe Keppra® is approved as: * Monotherapy in the treatment of partial-onset seizures with or without secondary generalization in patients from 16 years of age with newly diagnosed epilepsy * Adjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in adults and children from four years of age with epilepsy * Adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents from 12 years of age with juvenile myoclonic epilepsy * Adjunctive therapy for the treatment of primary generalised tonic clonic seizures in adults and adolescents from 12 years of age with idiopathic generalised epilepsyKeppra® provided the foundation for UCB's growing epilepsy franchisewhich has now been extended to include Vimpat® (lacosamide) which ismarketed in Europe as adjunctive therapy for the treatment ofpartial-onset seizures with or without secondary generalization inpatients with epilepsy, aged 16 years and older and in the U.S. asadjunctive therapy in the treatment of partial-onset seizures inpatients with epilepsy, aged 17 years and older. In the U.S. Vimpat®is a Schedule V controlled substance. Also, in the U.S. in 2008,Keppra® XR was approved as an add-on to other antiepileptictreatments for people with partial-onset seizures aged 16 years ofage and over.Further informationAntje Witte, Corporate Communications & Investor Relations, UCBT +32.2.559.9414, antje.witte(at)ucb.comRichard Simpson, Investor Relations, UCBT +32.2.559.9494, Richard.Simpson(at)ucb.comMichael Tuck-Sherman, Investor Relations, UCBT +32.2.559.9712, Michael.tuck-sherman(at)ucb.comNancy Nackaerts, External Communications, UCBT +32.2.559.9264, nancy.nackaerts(at)ucb.comEimear O'Brien, Associate Director, Global CNS Communications, UCBT +32.2.559.9271, Eimear.OBrien(at)ucb.comNotes to EditorsAbout EpilepsyEpilepsy is a chronic neurological disorder affecting 50 millionpeople worldwide. It is caused by abnormal, excessive electricaldischarges of the nerve cells or neurons in the brain. Epilepsy ischaracterized by a tendency to have recurrent seizures and defined bytwo or more unprovoked seizures. There are many different seizuretypes and epileptic syndromes and effective classification guidestreatment and prognosis.About Keppra® in EuropeKeppra® film coated tablets were first approved Europe in 2000 asadjunctive therapy in the treatment of partial-onset seizures with orwithout secondary generalization in patients with epilepsy, aged 16years and older. Since this time, Keppra® has received severaladditional indications.Please refer to the European Summary of Product Characteristics forfull prescribing and safety information:http://www.emea.europa.eu/humandocs/PDFs/EPAR/keppra/H-277-PI-en.pdf(accessed 19.06.09)About Vimpat® in EuropePlease refer to the European Summary of Product Characteristics forfull prescribing and safety information:http://www.emea.europa.eu/humandocs/PDFs/EPAR/vimpat/H-863-PI-en.pdfImportant U.S. Keppra® Safety InformationKeppra® tablets and oral solution are indicated as adjunctive therapyin the treatment of partial onset seizures in adults and children 4years of age or older with epilepsy, myoclonic seizures in adults andadolescents 12 years of age and older with juvenile myoclonicepilepsy, and primary generalized tonic-clonic seizures in adults andchildren 6 years of age and older with idiopathic generalizedepilepsy.Antiepileptic drugs (AEDs) increase the risk of suicidal thoughts orbehavior in patients taking these drugs for any indication. Patientstreated with any AED for any indication should be monitored for theemergence or worsening of depression, suicidal thoughts or behavior,and/or any unusual changes in mood or behavior.Keppra® tablets and oral solution are associated with the occurrenceof central nervous system adverse events including somnolence andfatigue, behavioral abnormalities, and coordination difficulties, aswell as hematological abnormalities. In pediatric patients 4-16 yearsof age experiencing partial onset seizures, the most common adverseevents associated with Keppra® in combination with other AEDs weresomnolence, accidental injury, hostility, nervousness and asthenia.In adults experiencing partial onset seizures, the most commonadverse events associated with Keppra® in combination with other AEDswere somnolence, asthenia, infection and dizziness. In patients 12years of age and older experiencing myoclonic seizures with juvenilemyoclonic epilepsy, the most common adverse events associated withKeppra® in combination with other AEDs were somnolence, neck pain,and pharyngitis. In patients 6 years of age and older experiencingPGTC seizures with idiopathic generalized epilepsy, the most commonadverse event associated with Keppra® in combination with other AEDswas nasopharyngitis.Keppra® injection is indicated as adjunctive therapy in the treatmentof partial onset seizures in adults with epilepsy, myoclonic seizuresin adults with JME, and PGTC seizures in adults with idiopathicgeneralized epilepsy. Keppra® injection is an alternative forpatients when oral administration is temporarily not feasible. Theadverse events that result from Keppra® injection use include all ofthose associated with Keppra® tablets and oral solution.Keppra® XR extended-release tablets are indicated as adjunctivetherapy in the treatment of partial-onset seizures in patients 16years of age and older with epilepsy. Keppra XR(TM) causessomnolence, dizziness, and behavioral abnormalities. The most commonadverse reactions observed with Keppra® XR in combination with otherAEDs were somnolence and irritability. The adverse reactions that maybe seen in patients receiving Keppra® XR are expected to be similarto those seen in patients receiving immediate-release Keppra®tablets. Keppra® XR should be gradually withdrawn to minimize thepotential of increased seizure frequency.For all Keppra® formulations, dosing must be individualized accordingto the patient's renal function status. In patients with end-stagerenal disease on dialysis, it is recommended that immediate-releaseKeppra® be used instead of Keppra XR(TM).Please see www.Keppra.com for U.S. full prescribing information andMedication Guide. Please see www.keppraxr.com for U.S. fullprescribing information and Medication Guide.Important U.S. Vimpat®safety informationVimpat® (lacosamide C-V) is a medicine that is used with othermedicines to treat partial onset seizures in patients 17 years of ageand older with epilepsy. Vimpat® is generally well-tolerated, but maynot be for everyone. Patients should discuss with their doctor ifVimpat® is right for them.The most common side effects with Vimpat® are dizziness, headache,nausea and double vision. Vimpat® may also cause problems withcoordination and balance. Patients should not drive, operatemachinery or do other dangerous activities until they know howVimpat® affects them. Patients should not stop taking Vimpat®without first talking to their doctor. Stopping Vimpat® suddenly cancause serious problems. Vimpat® could make patients feel faint.Patients should tell their doctor if they have a heart condition orif they are taking other medicines that affect the heart. In rarecases, Vimpat® may cause reactions that could affect the heart, liveror kidney. The patient should contact their doctor immediately ifthey are tired, have jaundice (yellowing of skin or eyes), and havedark urine. Antiepileptic drugs, including Vimpat®, may causesuicidal thoughts or actions in a very small number of people, about1 in 500. Patients should call their healthcare provider right awayif they have new or worsening symptoms of depression, any unusualchanges in mood or behavior, or suicidal thoughts, behavior, orthoughts about self harm that they have never had before or may beworse than before. To report SUSPECTED ADVERSE REACTIONS, contactUCB, Inc. at 866-822-0068 or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.Please see additional patient information including the Vimpat®Medication Guide at the end of the full prescribing information onwww.Vimpat.comAbout UCBUCB, Brussels, Belgium (www.ucb.com) is a biopharmaceutical companydedicated to the research, development and commercialization ofinnovative medicines with a focus on the fields of central nervoussystem and immunology disorders. Employing about 10 000 people inover 40 countries, UCB achieved revenues of EUR 3.6 billion in 2008.UCB is listed on Euronext Brussels (symbol: UCB).Forward looking statementThis press release contains forward-looking statements based oncurrent plans, estimates and beliefs of management. Such statementsare subject to risks and uncertainties that may cause actual resultsto be materially different from those that may be implied by suchforward-looking statements contained in this press release. Importantfactors that could result in such differences include: changes ingeneral economic, business and competitive conditions, effects offuture judicial decisions, changes in regulation, exchange ratefluctuations and hiring and retention of its employees.For the pdf-version of this press release, please click on the linkbelow:http://hugin.info/133973/R/1330646/314599.pdfThis announcement was originally distributed by Hugin. The issuer is solely responsible for the content of this announcement.
Datum: 24.07.2009 - 18:00 Uhr
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