SMYRNA, Ga., Oct. 27 /PRNewswire/ -- UCB Pharma, Inc. today announced that it filed a supplemental new drug application (sNDA) with the U.S. Food and Drug Administration (FDA) for the use of Keppra(R) (levetiracetam) as adjunctive therapy in the treatment of myoclonic seizures in adults and adolescents 12 years of age and older with juvenile myoclonic epilepsy (JME). Keppra(R) is currently approved for adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy.
JME is a common type of epilepsy that requires life-long treatment with anti-epileptic drugs (AEDs). While seizures associated with JME can usually be controlled with medication, a large number of patients with JME either don’t respond to or cannot tolerate standard first-line treatments. In addition, many JME patients are treated with inappropriate AEDs, which are either ineffective against myoclonic seizures or associated with unacceptable side effects.
This application for a new indication for Keppra(R) (levetiracetam) is based on the first double-blind, randomized, placebo-controlled study evaluating the efficacy and safety of an anti-epileptic drug in 120 patients (Keppra(R) N=60, placebo N=60) with idiopathic generalized epilepsy (IGE) who experience myoclonic seizures.
“A surprising number of patients (up to 45%) do not respond to current first line or newer therapies. This pivotal study shows that Keppra(R) may be an effective treatment option for these patients that are difficult to treat,” said study investigator Gregory Krauss, Associate Professor, Neurology, Johns Hopkins Medical School.
The study showed that Keppra(R) 3000 mg/day for 12 weeks reduced the rate of myoclonic seizure days by at least half in 58% of treated patients compared to 23.3% of placebo. A myoclonic seizure day was defined as any day in which a patient experienced one or more myoclonic seizures. Keppra(R) was generally well tolerated. Keppra(R) use was associated with somnolence and behavioral abnormalities. The most common adverse events not seen at an equivalent frequency among placebo patients were somnolence, neck pain and pharyngitis.
According to Peter Verdru, M.D., Vice President, Clinical Research, Head of Neurology/Psychiatry Clinical Development, UCB, “The new application represents another milestone in the development of Keppra(R) as a major advance in the management of epilepsy. No other anti-epileptic drug has undergone such rigorous testing to determine its safety and efficacy in patients suffering from idiopathic generalized epilepsy with myoclonic seizures.”
About Myoclonic Seizures and Juvenile Myoclonic Epilepsy
Myoclonic seizures are short, jerky muscle spasms that can occur once or repetitively, on one or both sides of the body.
They occur in a variety of epilepsy syndromes that have different characteristics. Myoclonic seizures are the hallmark symptom of a juvenile myoclonic epilepsy (JME) diagnosis. JME is classified as a type of idiopathic generalized epilepsy (IGE), in which seizures result from excessive electrical activity in the whole brain. JME is a common type of epilepsy that usually starts between the ages of 12 and 18, often around puberty, and accounts for 10% of all cases of epilepsy. JME requires life-long treatment with anti-epileptic drugs. Therefore, the goal of treatment is to achieve long-term seizure freedom, without side effects of medication. Myoclonic seizures are often overlooked, which may lead to misdiagnosis and inappropriate treatment; this is thought to explain why many patients with IGEs, such as JME, fail to respond to treatment.
About Keppra(R) (levetiracetam)
In the U.S., Keppra(R) is currently approved for adjunctive therapy in the treatment of partial onset seizures in adults and children 4 years of age and older with epilepsy. Keppra(R) is available in 250, 500 and 750 mg tablets and a grape-flavored (100 mg/mL) oral solution for patients who prefer a solution or have difficulty swallowing tablets. Keppra(R) dosing must be individualized according to renal function status. Since its launch, Keppra(R) has had more than 600,000 unique patient starts in the United States.
In adults, Keppra(R) use is associated with the occurrence of central nervous system adverse events, including somnolence and fatigue, coordination difficulties, and behavioral abnormalities as well as hematological abnormalities. In pediatric patients 4 to 16 years of age, Keppra(R) is associated with somnolence, fatigue, and behavioral abnormalities, as well as hematological abnormalities. In adults, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, asthenia, infection, and dizziness. Of these, most appeared to occur predominantly during the first 4 weeks of treatment. In pediatric patients 4 to 16 years of age, the most common adverse events associated with Keppra(R) in combination with other AEDs were somnolence, accidental injury, hostility, nervousness, and asthenia.
Keppra(R) (levetiracetam) was approved in 1999 as adjunctive therapy for adults with partial onset seizures and is the most prescribed second-generation AED used in epilepsy. For full prescribing information, please visit http://www.keppra.com.
As The Epilepsy Company, UCB has many programs for patients with epilepsy and their caregivers, including a dedicated web site geared toward epilepsy education. By logging onto http://ucbepilepsy.com, patients can obtain a variety of resources including a downloadable seizure diary and application forms for the newly established UCB scholarship program, which is unique as it provides financial assistance for epilepsy patients, their families and caregivers. UCB is also a proud sponsor of the Epilepsy Foundation’s H.O.P.E. Mentoring Program(TM) (Helping Other People with Epilepsy) that trains people with epilepsy to be “patient educators” throughout the epilepsy and neurology communities. H.O.P.E. mentors also conduct educational sessions for local social and civic groups in the community.
About UCB
UCB S.A. (http://www.ucb-group.com) is a global biopharmaceutical leader dedicated to the research, development, and commercialization of innovative products in the fields of central nervous system disorders, allergy and respiratory diseases, immune and inflammatory disorders and oncology. UCB employs over 8,500 people operating in over 40 countries, and achieved revenues of 2.1 billion euros (including net turnover, royalties, and fees) in 2004. UCB is listed on the Euronext Brussels with a market capitalization of approximately 5.5 billion euros. Worldwide headquarters are located in Brussels, Belgium.
UCB Pharma, Inc. is the North American subsidiary of UCB S.A., with U.S. headquarters located in Smyrna, Georgia. UCB key products in the U.S. are Keppra(R) (levetiracetam), Zyrtec(R)+ (cetirizine HCl), Tussionex(R) CIII (hydrocodone polistirex/chlorpheniramine polistirex), and Metadate CD(TM) CII (methylphenidate HCl, USP).
+ Zyrtec is licensed to and co-promoted with Pfizer, Inc. in the United
States.
* Keppra(R) (levetiracetam) is a registered trademark of the UCB S.A.
UCB Pharma, Inc.
CONTACT: Lisa Garman of UCB Pharma, Inc., +1-770-970-8569,lisa.garman@ucb-group.com; or Judi Kennedy of Chandler Chicco Agency,+1-212-229-8439, Jkennedy@ccapr.com, for UCB Pharma, Inc.
