UCB announced that the US Food and Drug Administration (FDA) has approved a supplemental new drug application (sNDA) for Briviact (brivaracetam) CV as monotherapy for partial-onset (focal) seizures (POS) in patients 16 years and older with epilepsy.

This is a new indication for Briviact, which is already approved in the US as adjunctive treatment for POS in patients in this age group. As a result, adults and adolescents aged 16 years and older with POS in the US can now be initiated on Briviact as monotherapy or adjunctive therapy.

Briviact is the newest antiepileptic drug (AED) in the ‘racetam’ class of medicines and demonstrates a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may contribute to its anticonvulsant effects. Gradual dose escalation is not required when initiating treatment with Briviact for monotherapy or adjunctive therapy, allowing clinicians to initiate treatment at a therapeutic dose from day one.

The most common adverse reactions (at least 5% for Briviact and at least 2% more frequently than placebo) are somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms.

“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 to match individual patient needs and circumstances,” explained Dr. Pavel Klein, 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.”

UCB submitted a supplemental application for a Briviact monotherapy indication taking into account a recent General Advice Letter, issued by the FDA, which stated it is acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of POS to their use as monotherapy for the treatment of POS. As a result of the FDA’s approach to assessing extrapolated data, UCB was able to support its Briviact monotherapy submission with a wealth of brivaracetam clinical trials data, which involved more than 2,400 adult patients with POS.

“We are delighted that, with this new monotherapy indication for Briviact, we can support people with epilepsy to reach their treatment goals. 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,” explained Jeff Wren, executive vice-president, head of UCB’s Neurology Patient Value Unit. “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. With this Briviact monotherapy indication, we build on our longstanding commitment to help people with seizure disorders at every point of their journey.”