FDA Approves Epilepsy Drug as Monotherapy for Partial-Onset Seizures

Today, the FDA has expanded the indication for brivaracetam (Briviact) as a monotherapy for partial-onset seizures (POS) in patients 16 years and older with epilepsy, according to a press release.

“This new monotherapy indication builds on an already strong and compelling clinical profile for Briviact, providing doctors the flexibility to tailor their choice of AED [antiepileptic drug] to match individual patient needs and circumstances,” said Pavel Klein, MD, director of the Mid-Atlantic Epilepsy and Sleep Center. “In helping to progress their journey towards seizure freedom by providing a choice of treatment which can be initiated as monotherapy, at a therapeutic dose, from day one, Briviact provides an additional treatment choice for neurologists and their patients.”

Brivaracetam previously received FDA approval as adjunctive treatment for POS in adults with epilepsy. Due to the new approval, the drug can be used as a monotherapy or an adjunctive therapy in adult patients with epilepsy.

The submission of a supplemental application for brivatacetam monotherapy was the result of an advice letter from the FDA, which said that it would be reasonable to extrapolate the efficacy and safety of the drug as a monotherapy, according to the release.

UCB was able to support the submission with positive data from clinical trials that included more than 2400 adults with epilepsy.

“We are delighted that, with this new monotherapy indication for Briviact, we can support people with epilepsy to reach their treatment goals,” said Jeff Wren, executive vice president, head of UCB’s Neurology Patient Value Unit. “Coming just 18 months after our launch in the US, this is evidence of our commitment to increasing the speed at which our therapies are approved and made available to as many patients as possible.”

Brivaracetam is an AED in the racetam class. Findings suggest that the drug works by targeting the synaptic vesicle protein 2A in the brain to prevent seizures. UCB reports that dose escalation is unnecessary for monotherapy or adjunctive treatment, which allows physicians to start patients on the appropriate dose immediately.

Common adverse events include somnolence, sedation, dizziness, fatigue, nausea, and vomiting, according to the release.

“Discovering, validating and improving access to new and innovative solutions to support people living with epilepsy has been, and will continue to be, a core UCB mission,” Wren concluded. “With this BRIVIACT monotherapy indication, we build on our longstanding commitment to help people with seizure disorders at every point of their journey.”