Brussels (Belgium), September 1, 2014— UCB announced today that the U.S. Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for VIMPAT® (lacosamide) C-V as monotherapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.1 This is a new indication for VIMPAT® which is already approved in the U.S. as adjunctive treatment for partial-onset seizures in patients in this age group.1 This new indication means that adults with partial-onset seizures can be initiated on VIMPAT® monotherapy, and patients already on an anti-epileptic drug can be converted to VIMPAT® monotherapy.
UCB also announced today that the FDA has approved a new single loading dose administration option for all formulations of VIMPAT®, when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.1
“People living with epilepsy have individual needs. It’s our aim at UCB to provide as many patients as possible with various options to reduce their seizures. Now, physicians and epilepsy patients in the U.S. have more VIMPAT® options to treat partial-onset seizures — VIMPAT® as an initial monotherapy, converting to VIMPAT® monotherapy and VIMPAT® as an adjunctive therapy. In addition, based on individual patients’ needs, physicians can choose between VIMPAT® formulations - tablets, oral solution or injection. Also, initiation of VIMPAT® as a single loading dose provides physicians with an alternative administration option to the standard titration schedule,” said Professor Dr. Iris Loew Friedrich, Chief Medical Officer and Executive Vice President, UCB.
The new U.S. monotherapy approval for VIMPAT® is based on a Phase 3 historical-control conversion to lacosamide monotherapy study in adult epilepsy patients with partial-onset seizures.1 The study met its primary endpoint, demonstrating that the exit percentage, defined as the estimated percentage of patients meeting pre-defined exit criteria, for patients converting to lacosamide 400 mg/day was significantly lower than the historical control exit percentage, used as a comparator. Lacosamide 300 mg/day also met the pre-specified criteria for efficacy.1
The most common adverse reactions in the monotherapy study were similar to those seen in adjunctive therapy studies; however, one adverse reaction, insomnia, was observed at a rate of ≥2% and was not reported at a similar rate in previous studies. Insomnia has also been observed in postmarketing experience. Because this study did not include a placebo control group, causality could not be established. In adjunctive therapy studies, the most common adverse reactions (≥10% and greater than placebo) were dizziness, headache, nausea and diplopia. Additional important safety information for VIMPAT® in the U.S. is available below.1
VIMPAT® Single Loading Dose
The new single loading dose administration option for VIMPAT® as monotherapy or adjunctive treatment of partial-onset seizures in adults with epilepsy allows the initiation of VIMPAT® as a single loading dose of 200 mg (oral or injection), followed approximately 12 hours later by a 100 mg twice daily dose (200 mg/day). The most common loading dose adverse events (≥5%) were dizziness, headache, paraesthesia and gait disturbance. The loading dose should be administered with medical supervision considering the VIMPAT® pharmacokinetics and increased incidence of CNS adverse reactions.1
VIMPAT® in the European Union
In the European Union, VIMPAT® is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. VIMPAT® may also be initiated with a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice daily (200 mg/day) maintenance dose regimen. Additional important information on VIMPAT® loading dose in the European Union is available below. VIMPAT® is not approved in the European Union as monotherapy.3
A non-inferiority monotherapy study is underway to support the potential monotherapy filing with the European Medicines Agency. The study aims to compare the efficacy and safety of lacosamide to carbamazepine controlled-release as monotherapy in newly or recently newly diagnosed patients (≥ 16 years) with partial-onset seizures.4
VIMPAT® is approved in the U.S. as tablets, injection and oral solution as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in people with epilepsy ages 17 years and older. VIMPAT® injection is a short-term replacement when oral administration is not feasible in these patients. The availability of the oral tablets, oral solution, and intravenous (IV) injection formulations permits flexibility in administration.
A single loading dose administration option is also approved in the U.S. for all formulations of VIMPAT® when used as monotherapy or adjunctive therapy in the treatment of partial-onset seizures in patients with epilepsy aged 17 years and older.
Since the initial launch of VIMPAT® tablets and injection in May 2009, there have been more than 200,000* VIMPAT® patient exposures in the U.S.
In the European Union, VIMPAT® (film-coated tablets, syrup and solution for infusion) is approved as adjunctive therapy for the treatment of partial-onset seizures with or without secondary generalization in adult and adolescent (16-18 years) patients with epilepsy. VIMPAT® is also approved in the European Union for initiation as a single loading dose of 200 mg, followed approximately 12 hours later by a 100 mg twice-daily maintenance dose regimen.
Important safety information about VIMPAT® in the U.S. and the European Union is available below.
IMPORTANT SAFETY INFORMATION ABOUT VIMPAT® IN THE U.S.
Warnings and Precautions