Posted by Michael Wonder on 18 Sep 2017
New indication for Briviact (brivaracetam): UCB’s newest anti-epileptic drug approved by FDA as monotherapy treatment of partial-onset seizures in adults
15 September 2017 - Approval applies a newly established regulatory pathway which allows monotherapy treatment options to reach epilepsy patients sooner.
UCB announced today that the U.S. FDA has approved a supplemental new drug application 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.
