US and EU regulatory filings for UCB's antiepileptic brivaracetam

21 January 2015

Belgium’s largest pharma company UCB (Euronext Brussels: UCB) today announced regulatory filings in the USA and the European Union for its investigational antiepileptic drug brivaracetam. However, the company’s shares dipped 1.6% to 68.58 euros by early afternoon trading.

In the USA, the Food and Drug Administration has accepted for review the New Drug Application for brivaracetam as adjunctive therapy for the treatment of partial-onset seizures in patients from 16 years of age with epilepsy, and in the EU, the European Medicines Agency has validated for review the Marketing Authorization Application for brivaracetam in the same proposed indication. Acceptance for review indicates that the FDA and EMA have found the company's submissions to be sufficiently complete to proceed.

Will add to the company’s epilepsy franchise

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