FDA grants pediatric exclusivity for UCB's Keppra

UCB has announced that the US Food and Drug Administration (FDA) has granted pediatric exclusivity for Keppra (levetiracetam). The decision was based on pediatric data submitted to the FDA following a written request in 2001.

The Keppra US '639 patent was set to expire in July 2008, however, this grant extends the period of exclusivity on Keppra across all licensed indications by six months to January 2009.

UCB also announced today that the US FDA has accepted for filing and six-month priority review the supplementary New Drug Application (sNDA) for Keppra as adjunctive treatment of partial onset seizures in infants and children with epilepsy, aged from one month to under four years.

"The FDA's filing acceptance and granting of priority review status reflects the need for new effective antiepileptic treatments for infants and children under four years," said Iris Loew-Friedrich, MD, PhD, Chief Medical Officer, UCB. "The trials supporting this sNDA included the third well-controlled trial of Keppra in a pediatric population, with studies in partial onset seizures now extending from infants to children and adolescents."

The submission was based on multiple efficacy, safety and pharmacokinetic studies including data from a Phase III, double-blind, randomized, multi-center, placebo-controlled study evaluating the efficacy and tolerability of levetiracetam oral solution (20-50 mg/kg/day) in 116 pediatric patients with refractory partial onset seizures, aged from one month to under four years. Prior to treatment, infants and children in this study were experiencing at least two partial onset seizures per week despite treatment with one or two other antiepileptic drugs.

Levetiracetam was shown to significantly reduce the frequency of partial onset seizures with 43.1% of levetiracetam-treated patients experiencing at least a 50% reduction in seizure frequency during the evaluation period (five days) compared with 19.6% of placebo-treated patients (p=0.013). Levetiracetam was generally well-tolerated in this pediatric population. The most commonly reported adverse events that occurred more frequently in the treatment group were somnolence (13.3% vs. 1.8% for placebo) and irritability (11.7% vs. 0 for placebo). The incidence of other adverse events was similar in both groups.

In October 2007, UCB announced that it had reached an agreement to settle pending patent infringement lawsuits in the US. Under the terms of the settlement agreement with Mylan, and subject to its receiving FDA approval, Mylan will be allowed to sell its generic levetiracetam tablets effective November 1, 2008, in advance of the expiry of UCB's market exclusivity on January 14, 2009.