FDA to Review Briviact as Monotherapy for Partial-Onset Seizures
UCB has filed a supplemental New Drug Application (sNDA) for Briviact (brivaracetam) as monotherapy to treat partial-onset seizures in patients ≥16 years with epilepsy.
The filing comes after the Food and Drug Administration (FDA) stated in a General Advice Letter that it is “acceptable to extrapolate the efficacy and safety of drugs approved as adjunctive therapy for the treatment of partial onset seizures (POS) to their use as monotherapy for the treatment of POS.” Briviact is already approved as an adjunctive therapy to treat partial-onset seizures for those ≥16 years old.
Brivaracetam has a high and selective affinity for synaptic vesicle protein 2A (SV2A) in the brain, which may play a part in the anticonvulsant effect. However, the precise mechanism of action of Briviact is unknown.
“This submission, under the FDA's extrapolation principle, allows us to use the strength of our brivaracetam clinical trials data […] and reinforces our longstanding commitment to develop and make available meaningful treatment solutions to improve the lives of people living with epilepsy,” said Dr. Iris Loew-Friedrich, CMO of UCB.
The FDA has stipulated that to support extrapolation as a monotherapy, any proposed dosages should result in exposures similar to those demonstrated to be safe and effective when the drug is used as adjunctive therapy. UCB stated that they have included this information in their sNDA.
For more information visit UCB.com.