Posted by Michael Wonder on 22 Jan 2017
UCB files Briviact (brivaracetam) CV in the U.S. as monotherapy treatment for adult epilepsy patients with partial-onset seizures
19 January 2017 - Application follows recent FDA general advice letter supporting use of extrapolated data to assess monotherapy use of drugs already approved as adjunctive therapy.
UCB has today announced the filing of a supplemental New Drug Application (sNDA) to the U.S. FDA for Briviact (brivaracetam) CV as monotherapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy within the U.S.
Briviact is currently approved in the U.S. as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy.
