Catalyst
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U.S. FDA approves UCB's new epilepsy treatment, BRIVIACT, for patients with partial-onset seizures
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Additional Information
The most common adverse reactions occurring at a frequency of at least 5% in patients treated with BRIVIACT doses of at least 50 mg/day and greater than placebo were somnolence and sedation, dizziness, fatigue, and nausea and vomiting symptoms. The discontinuation rate due to adverse events was 5%, 8%, and 7% for patients randomized to receive BRIVIACT at the recommended doses of 50 mg, 100 mg, and 200 mg/day, respectively, compared to 4% in patients randomized to receive placebo.
- BRIVIACT (brivaracetam), a new molecular entity, is indicated as adjunctive therapy in the treatment of partial-onset seizures in patients 16 years of age and older with epilepsy
- The approximately 30% of people with epilepsy whose seizures remain uncontrolled on currently available therapies can experience devastating physical and emotional consequences as a result.
- Phase 3 data showed BRIVIACT significantly reduced the frequency of partial-onset seizures over placebo.
- The FDA approval of BRIVIACT once again demonstrates UCB’s commitment to and expertise in delivering promising new treatments to people living with epilepsy; regulatory filings in countries worldwide are underway
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Catalyst Date
Occurred on:
Feb 19, 2016
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Related Keywords
Brivaracetam, Briviact, Sedation, Dizziness, Fatigue, Nausea, Vomiting
