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news.The US Food and Drug Administration (FDA) has granted approval for UCB's supplemental new drug application (sNDA) for Vimpat (lacosamide) C-V as monotherapy to treat partial-onset seizures in patients with epilepsy.
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In the US, Vimpat is already approved as adjunctive treatment for partial-onset seizures in patients belonging to this age group.
The new indication means that adults aged 17 years and older with partial-onset seizures can now be tested on Vimpat monotherapy, while patients already on an anti-epileptic drug can be converted to the monotherapy.
The single loading dose administration option allows the initiation of Vimpat as a single loading dose of 200mg (oral or injection), followed about 12 hours later by a 100mg twice daily dose (200mg/day).
The FDA has also approved a new single loading dose administration option for all formulations of Vimpat, when used as monotherapy or adjunctive therapy to treat these patients.
UCB chief medical officer and executive vice-president Dr Iris Loew Friedrich said 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," Friedrich said.
"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."
The FDA approval for the new Vimpat monotherapy is based on a Phase III historical-control conversion to lacosamide monotherapy trial in adult epilepsy patients with partial-onset seizures.
The company said that the trial met its primary endpoint, showing that the exit percentage, defined as the estimated percentage of patients meeting pre-defined exit criteria, for patients converting to lacosamide 400mg/day was significantly lower than the historical control exit percentage, used as a comparator.
Image: The FDA approval allows the company to offer Vimpat as a single loading dose of 200mg oral or injection. Photo: courtesy of Baitong333/ freedigitalphotos.net