Introduction to BRIVIACT
BRIVIACT, or brivaracetam, is an anti-epileptic drug developed by UCB, designed to treat partial-onset seizures in patients aged 16 years and older. It belongs to the ‘racetam’ class of medicines, which have a high, selective affinity for synaptic vesicle protein 2A (SV2A), contributing to its anticonvulsant effects[3].
Clinical Trials Overview
Trial Design and Participants
The FDA approved BRIVIACT based on evidence from three clinical trials involving 1,558 patients with partial-onset seizures. These trials were conducted globally, including in the USA, Canada, Europe, Latin America, Asia, and Australia. The trials were randomized, double-blind, placebo-controlled, and multicenter, with patients receiving either BRIVIACT or a placebo in addition to their usual antiseizure medications (ASMs)[4].
Efficacy in Focal Seizures
The clinical trials demonstrated the efficacy of BRIVIACT in reducing focal seizure frequency. Across the three trials, BRIVIACT showed a significant reduction in seizure frequency compared to the placebo group. Specifically, the percent reduction in focal seizure frequency adjusted to 28 days during the treatment period was notable, with low discontinuation rates due to adverse events (4% for placebo, 5% for 50 mg/day, 8% for 100 mg/day, and 7% for 200 mg/day)[1].
Secondarily Generalized Tonic-Clonic (SGTC) Seizures
BRIVIACT also showed promising results in patients with SGTC seizures. From a baseline of approximately three SGTC seizures per 28 days, more than one in three patients achieved zero SGTC seizures in both the short-term (12-week) and long-term (5-year) follow-up analyses. Notably, approximately half of the patients achieved seizure freedom for a year or more when BRIVIACT was used earlier in the treatment regimen[1].
Safety and Tolerability
The clinical trials highlighted the safety and tolerability profile of BRIVIACT. The drug was studied in a difficult-to-treat patient population, including refractory patients who had taken five or more ASMs. Despite this, the discontinuation rates due to adverse events were relatively low, indicating good tolerability[1].
Market Analysis
Current Market Performance
BRIVIACT has shown strong market performance, contributing significantly to UCB's revenue growth. In the first half of 2024, BRIVIACT demonstrated double-digit growth in all regions where it is available, aligning with UCB's overall revenue increase of €2.79 billion (+8%; +10% CER)[2].
Market Penetration and Expansion
UCB is expected to continue expanding BRIVIACT's market penetration. The drug has been approved as a monotherapy for partial-onset seizures, expanding its potential patient population. GlobalData anticipates further supplementary new drug applications (sNDAs), potentially including approval for pediatric patients, which could extend the drug's exclusivity period and delay generic entry[3].
Global Launches and Projections
BRIVIACT is forecast to launch in all seven major markets (7MM) and is anticipated to reach peak sales of $353 million by 2025, making it one of the highest-selling anti-epileptic drugs on the market. UCB's strategic launches and marketing efforts, including direct-to-consumer campaigns, are expected to drive continued growth for BRIVIACT[3].
Projections and Future Outlook
Revenue Guidance
UCB's financial guidance for 2024 includes an expected increase in revenues, with BRIVIACT being a key contributor to this growth. The company aims to reach the top end of its revenue guidance range of €5.5-€5.7 billion, driven by the continued solid contributions from its existing product portfolio, including BRIVIACT[2].
Clinical and Regulatory Pipeline
UCB continues to innovate and expand its clinical and regulatory pipeline. The company is committed to advancing its late-stage and early development pipeline, which includes several phase 3 and phase 2a projects. This ongoing innovation is expected to further solidify BRIVIACT's position in the epilepsy market[2].
Key Takeaways
- Efficacy: BRIVIACT has demonstrated significant efficacy in reducing focal and SGTC seizure frequencies in clinical trials.
- Safety and Tolerability: The drug has shown a favorable safety and tolerability profile, even in difficult-to-treat patient populations.
- Market Performance: BRIVIACT has contributed to UCB's revenue growth with double-digit growth in all regions.
- Market Expansion: UCB is expected to expand BRIVIACT's market penetration through additional approvals and strategic launches.
- Future Outlook: BRIVIACT is projected to reach peak sales of $353 million by 2025 and remains a key driver of UCB's revenue growth.
FAQs
What is BRIVIACT used for?
BRIVIACT (brivaracetam) is used for the treatment of partial-onset seizures in patients aged 16 years and older with epilepsy[4].
How effective is BRIVIACT in reducing seizures?
BRIVIACT has shown a significant reduction in focal and SGTC seizure frequencies in clinical trials, with more than one in three patients achieving zero SGTC seizures in both short-term and long-term analyses[1].
Is BRIVIACT safe and well-tolerated?
Yes, BRIVIACT has demonstrated a favorable safety and tolerability profile, with low discontinuation rates due to adverse events, even in difficult-to-treat patient populations[1].
What are the market projections for BRIVIACT?
BRIVIACT is forecast to reach peak sales of $353 million by 2025 and is expected to continue driving UCB's revenue growth through its strong market performance and planned expansions[3].
Are there plans for BRIVIACT to be approved for pediatric patients?
Yes, GlobalData anticipates that UCB will seek approval for BRIVIACT in pediatric patients, which could extend the drug's exclusivity period and delay generic entry[3].
References
- BRIVIACT® (brivaracetam) prescribing information. Smyrna, GA: UCB, Inc.
- UCB Press Release: Strong Start into UCB's Decade of Growth. UCB, July 25, 2024.
- UCB's latest anti-epileptic drug advances in the epilepsy market. Clinical Trials Arena, September 25, 2017.
- Drug Trials Snapshot: Briviact. FDA, March 8, 2016.
