TOKYO, Japan I May 27, 2015 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Ltd. has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of Fycompa(R) (perampanel) for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in adult and adolescent patients from 12 years of age with idiopathic generalized epilepsy.
PGTC seizures are one of the most common and most severe forms of generalized seizures, accounting for approximately 60% of generalized epilepsy and approximately 20% of all epilepsy cases.*1 The CHMP based its opinion on a multicenter, double-blind, randomized, placebo-controlled, parallel-group study (Study 332) to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older with PGTC seizures receiving one to a maximum of three anti-epileptic drugs.*2 As one of the primary endpoints of the study, the responder rate for Fycompa was 64.2%, which was a statistically significant improvement over the responder rate for placebo of 39.5% (p=0.0019). Additionally, a reduction in PGTC seizure frequency of 76.5% was observed in the Fycompa group, which was statistically significant when compared to a reduction of 38.4% for placebo (p<0.0001). Furthermore, 30.9% of patients treated with Fycompa were free of PGTC seizures (12.3% for placebo) during the 13 week maintenance period. The most common adverse events for Fycompa and placebo were, respectively, dizziness, fatigue, headache, somnolence and irritability.
Fycompa is a first-in-class AED discovered and developed by Eisai. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.
Epilepsy affects nearly 2.4 million people in Europe (G5). Fycompa was launched in Europe as an adjunctive treatment for partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older in September 2012. Currently the agent is approved for this indication in over 45 countries, and has been launched in over 25 countries.
Eisai considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to Fycompa as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.
*1 Hauser WA, et al. Epilepsia, 34(3):453-468,1993
*2 French JA, et al. “Adjunctive Perampanel for Treatment of Drug-Resistant Primary Generalized Tonic-Clonic Seizures in Patients with Idiopathic Generalized Epilepsy: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial.” Abstract. 68th American Epilepsy Society (AES) Annual Meeting, 2014; 2.389
SOURCE: Eisai
Post Views: 27
TOKYO, Japan I May 27, 2015 I Eisai Co., Ltd. (Headquarters: Tokyo, CEO: Haruo Naito, “Eisai”) announced today that its U.K. subsidiary Eisai Europe Ltd. has received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for the use of Fycompa(R) (perampanel) for the adjunctive treatment of primary generalized tonic-clonic (PGTC) seizures in adult and adolescent patients from 12 years of age with idiopathic generalized epilepsy.
PGTC seizures are one of the most common and most severe forms of generalized seizures, accounting for approximately 60% of generalized epilepsy and approximately 20% of all epilepsy cases.*1 The CHMP based its opinion on a multicenter, double-blind, randomized, placebo-controlled, parallel-group study (Study 332) to evaluate the efficacy and safety of adjunctive Fycompa therapy in 164 patients aged 12 years and older with PGTC seizures receiving one to a maximum of three anti-epileptic drugs.*2 As one of the primary endpoints of the study, the responder rate for Fycompa was 64.2%, which was a statistically significant improvement over the responder rate for placebo of 39.5% (p=0.0019). Additionally, a reduction in PGTC seizure frequency of 76.5% was observed in the Fycompa group, which was statistically significant when compared to a reduction of 38.4% for placebo (p<0.0001). Furthermore, 30.9% of patients treated with Fycompa were free of PGTC seizures (12.3% for placebo) during the 13 week maintenance period. The most common adverse events for Fycompa and placebo were, respectively, dizziness, fatigue, headache, somnolence and irritability.
Fycompa is a first-in-class AED discovered and developed by Eisai. The agent is a highly selective, noncompetitive AMPA receptor antagonist that reduces neuronal hyperexcitation associated with seizures by targeting glutamate activity at postsynaptic AMPA receptors.
Epilepsy affects nearly 2.4 million people in Europe (G5). Fycompa was launched in Europe as an adjunctive treatment for partial-onset seizures (with or without secondary generalized seizures) in patients with epilepsy aged 12 years and older in September 2012. Currently the agent is approved for this indication in over 45 countries, and has been launched in over 25 countries.
Eisai considers epilepsy a therapeutic area of focus and by providing multiple treatment options in addition to Fycompa as part of an extensive epilepsy product portfolio, Eisai seeks to make continued contributions to address the diverse needs of, as well as increasing the benefits provided to, patients with epilepsy and their families.
*1 Hauser WA, et al. Epilepsia, 34(3):453-468,1993
*2 French JA, et al. “Adjunctive Perampanel for Treatment of Drug-Resistant Primary Generalized Tonic-Clonic Seizures in Patients with Idiopathic Generalized Epilepsy: A Double-Blind, Randomized, Placebo-Controlled Phase III Trial.” Abstract. 68th American Epilepsy Society (AES) Annual Meeting, 2014; 2.389
SOURCE: Eisai
Post Views: 27
