) announced positive top-line results from a phase III study
(n=768) on epilepsy candidate, brivaracetam. Brivaracetam achieved
a statistically significant reduction in partial-onset seizure
frequency and improved responder rates in the patients compared to
In the randomized, double-blind, placebo-controlled, multi-center,
parallel-group phase III study (N01358) UCB evaluated the efficacy
and safety of brivaracetam, for a 12-week period, as an adjunctive
treatment in patients (16 − 80 years of age) suffering from focal
epilepsy with partial-onset seizures, and who have not achieved
full control despite undergoing treatment with one or two
concomitant antiepileptic drugs. This study was the last one
scheduled under the phase III program on brivaracetam.
The phase III program comprises four studies, N01252, N01253,
N01254 and N01358. In the aforementioned N01358 study,
brivaracetam's tolerability was consistent with that found in the
Epilepsy is a chronic neurological disorder that affects nearly 65
million people across the world. According to the press release
issued by UCB, almost 1 out of 26 people are expected to develop
epilepsy in their lifetime.
On the basis of results from the phase III program, UCB intends to
file for approval of brivaracetam in the U.S. and the EU in early
A drug already approved as an adjunctive treatment of partial-onset
seizures in adults is
) Potiga (brand name in Europe: Trobalt).
We are encouraged by the positive phase III results on
brivaracetam. We note that UCB has a strong franchise in epilepsy.
The successful development and commercialization of brivaracetam
will help strengthen the company's position in the market for
Investors looking for well-positioned stocks in the biotech sector
Biogen Idec Inc.
), which carries a Zacks Rank #1 (Strong Buy).
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