UCB epilepsy drug reaches regulatory bodies
pharmafile | January 21, 2015 | News story | Research and Development, Sales and Marketing | EMA, FDA, UCB, brivaracetam, epilepsy
UCB has established regulatory milestones for its investigational antiepileptic drug brivaracetam in Europe and the US.
The Food and Drug Administration (FDA) and European Medicines Agency (EMA) have both accepted a review of the medication to treat adult epilepsy patients with uncontrolled partial-onset seizures.
The filings for the treatment come after the Brussels-based biopharma firm reported positive results for brivaracetam during its Phase III study back in July last year.
“Today is a major milestone for brivaracetam and an exciting day for everyone at UCB who is committed to its development,” explains Professor Iris Loew-Friedrich, who is the chief medical officer and executive vice president of UCB.
Study results show that brivaracetam reduced partial-onset seizure frequency and improved responder rates. “We look forward to working closely with the FDA and EMA through the review process,” adds Loew-Friedrich.
Epilepsy is a chronic neurological disorder affecting around 65 million people worldwide and more than two million people in the US alone. The condition can develop at any age with one in 26 people developing epilepsy in their lifetime.
The Belgium company claims that its newest product to emerge from the firm’s late-stage pipeline “is leading the way for UCB’s new era of patient-centric solutions.” UCB incidentally just announced last week it was hiring a new chief executive in Jean-Christophe Tellier.
He replaces Doliveux in the top job after he stepped down on 31 December after leading the company for the last 10 years.
Tom Robinson
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