The FDA has approved a monotherapy indication for UCB’s Vimpat in the treatment of epilepsy.
The approval means the drug can now be used by itself to treat partial-onset seizures in adult patients with epilepsy. This expands the use of Vimpat (lacosamide) beyond its 2008 approval as an adjunctive treatment in this group of patients.
The terms of the US regulator’s new recommendation mean that adults in the country with partial-onset seizures can receive can receive Vimpat monotherapy as an initial treatment and patients already on an epilepsy treatment can switch to monotherapy with Vimpat.
The drug is one of UCB’s main products going forward as it looks to overcome the loss of sales for older epilepsy treatment Keppra (levetiracetam) due to generic competition.
Vimpat achieved revenues of €217m for the first six months of 2014 and its monotherapy approval should see sales increase considerably, if UCB can compete effectively with current treatments, such as lamotragine and topiramate.
Extra treatment options for epilepsy patients are important because the complexities of the disease require a very personalised approach to care.
“It’s our aim at UCB to provide as many patients as possible with various options to reduce their seizures,” said UCB’s chief medical officer Prof Dr Iris Loew Friedrich. “Now, physicians and epilepsy patients in the US have more Vimpat options to treat partial-onset seizures.”
In addition to the monotherapy approval, the FDA also recommended a new single loading dose administration option for all formulations of Vimpat.
UCB also has plans to submit the drug for monotherapy approval in the EU, expanding its existing adjunctive indication in the region.
To support this UCB is in the middle of a study comparing the efficacy and safety of lacosamide to a controlled-release version of carbamazepine as monotherapy in newly or recently newly diagnosed epilepsy patients with partial-onset seizures.