FDA approves supplemental new drug application for Briviact (brivaracetam) as monotherapy for partial-onset seizures in patients 16 years and older with epilepsy.- UCB.

UCB announced that the U.S. 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 U.S. 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 U.S. can now be initiated on Briviact as monotherapy or adjunctive therapy.

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. 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.