SMYRNA, Ga., June 6 UCB announced today that the US Foodand Drug Administration (FDA) has granted pediatric exclusivity for Keppra(R)(levetiracetam). The decision was based on pediatric data submitted to the FDAfollowing a written request in 2001. The Keppra(R) US '639 patent was set toexpire in July 2008, however, this grant extends the period of exclusivity onKeppra(R) across all licensed indications by six months to January 2009.
UCB also announced today that the US FDA has accepted for filing andsix-month priority review the supplementary New Drug Application (sNDA) forKeppra(R) as adjunctive treatment of partial onset seizures in infants andchildren with epilepsy, aged from one month to under four years.
"The FDA's filing acceptance and granting of priority review statusreflects the need for new effective antiepileptic treatments for infants andchildren under four years," said Iris Loew-Friedrich, MD, PhD, Chief MedicalOfficer, UCB. "The trials supporting this sNDA included the thirdwell-controlled trial of Keppra(R) in a pediatric population, with studies inpartial onset seizures now extending from infants to children andadolescents."
The submission was based on multiple efficacy, safety and pharmacokineticstudies including data from a Phase III, double-blind, randomized,multi-center, placebo-controlled study evaluating the efficacy andtolerability of levetiracetam oral solution (20-50 mg/kg/day) in 116 pediatricpatients with refractory partial onset seizures, aged from one month to underfour years. Prior to treatment, infants and children in this study wereexperiencing at least two partial onset seizures per week despite treatmentwith one or two other antiepileptic drugs.
Levetiracetam was shown to significantly reduce the frequency of partialonset seizures with 43.1% of levetiracetam-treated patients experiencing atleast a 50% reduction in seizure frequency during the evaluation period (fivedays) compared with 19.6% of placebo-treated patients (p=0.013). Levetiracetamwas generally well-tolerated in this pediatric population. The most commonlyreported adverse events that occurred more frequently in the treatment groupwere somnolence (13.3% vs. 1.8% for placebo) and irritability (11.7% vs. 0 forplacebo). The incidence of other adverse events was similar in both groups.
In October 2007, UCB announced that it had reached an agreement to settlepending patent infringement lawsuits in the US. Under the terms of thesettlement agreement with Mylan, and subject to its receiving FDA approval,Mylan will be allowed to sell its generic levetiracetam tablets effectiveNovember 1, 2008, in advance of the expiry of UCB's market exclusivity onJanuary 14, 2009.
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 Keppra(R) in the US: Keppra(R) (levetiracetam) tablets were firstapproved by the FDA in 1999 as adjunctive therapy in the treatment of partialonset seizures in adults with epilepsy. Since 1999, Keppra(R) has receivedseveral supplemental indications as adjunctive therapy for epilepsy.
Important Safety Information
Keppra(R) tablets and oral solution are i