Belgian pharma company UCB has filed its investigational drug brivaracetam for approval to treat epilepsy in both the US and EU.
Both the US FDA and the European Medicines Agency (EMA) have accepted brivaracetam for review as an adjunctive therapy for the treatment of partial-onset seizures in epilepsy patients over 16 years of age.
Dr Iris Loew-Friedrich, chief medical officer and executive VP at UCB, commented: “Today is a major milestone for brivaracetam and an exciting day for everyone at UCB who is committed to its development.
“It is also an important time for the clinicians and patients whose involvement in brivaracetam clinical trials has been so important in helping up to address the need for new treatment options for adult patients who do not achieve partial-onset seizure control with current antiepileptic drugs.”
The filings are supported by data from three phase III studies, which evaluated the efficacy and safety of adjunctive brivaracetam in a 5-200mg daily dosage in patients with uncontrolled partial-onset seizures.
A fourth phase III study evaluated the safety and tolerability of adjunctive brivaracetam given to patients with the same symptoms.
The filing is a major milestone for UCB as it pursues its goal of building its epilepsy business following the loss of patent for Keppra in the US and EU in the past few years.
The company has since turned to other drugs in its epilepsy portfolio, including Vimpat (lacosamide). At the end of last year UCB announced a partnership with Daiichi Sankyo to bring Vimpat to Japan.