3 From Patient Value Strategy to action in epilepsy
- Bringing different treatment options: Keppra®, Vimpat® and Briviact® to more than 2.8 million patients
- Getting faster access to patients thanks to innovative extrapolation
- Acquiring midazolam nasal spray
- Exploring potential of new technologies
- 1 in 3 patients still have uncontrolled seizures4
- Over 30 different types of seizures4
- Further research on Keppra® enabled UCB scientists to continue their discoveries in epilepsy
- Next step: identifying new treatments that can prevent or cure epilepsy
Patients are still waiting
Today, nearly 60% of patients newly diagnosed with epilepsy become seizure free with their ﬁrst anti-epileptic drug3. But for 30-40% of patients, seizures remain uncontrolled4. These are the great challenges we continue to tackle.
To date, more than 30 different types of seizures have been identiﬁed. From one patient to another, seizure types and frequency vary greatly. Some are short, like muscle jerks, while others are prolonged convulsions. Some patients may experience them rarely, while others battle seizures multiple times per day. Focal seizures start in just one part of the brain, while generalized seizures are the result of simultaneous abnormal activity of the whole brain. Epilepsy can be triggered by head injuries, strokes, brain damage at birth and brain tumors4; but a vast majority of cases seem to have no apparent cause5. One thing patients battling epilepsy all have in common: they all want to regain control – a primary goal leading to a higher quality of life. We cannot go for a “one fits all” approach anymore.
UCB’s expertise in the field of epilepsy is widely recognized in the scientific and medical communities. Our story began several decades ago when a group of UCB scientists in Braine-l’Alleud (Belgium) discovered one molecule with a unique profile in epilepsy models. Showing their confidence, they challenged the conventional scientific approach to test new epilepsy treatments and continued their research which identified a truly novel mechanism for levetiracetam that eventually became the first blockbuster drug in epilepsy under the brand name Keppra®.
Keppra® opened the door to a whole new approach to treat epilepsy with a radically new mechanism of action, correlating novel activity profiles of molecules in innovative preclinical models. This approach generated projects such as Briviact®, padsevonil and also led to the identification of novel compounds for treatment of cognitive disorders. The latter triggered the creation of a spin-off company, Syndesi Therapeutics.
UCB continues exploring how new technologies and big data may improve diagnosis and treatment of epilepsy such as eliprio™, a program that harnesses predictive analytics and machine learning to personalize epilepsy treatment. Another example is our investment in Ceribell, an exciting Silicon Valley based healthcare startup developing a novel, innovative and disruptive clinical quality portable EEG system which allows for instant epilepsy diagnosis.
UCB has made a major contribution for improving epilepsy care by bringing different treatment options to patients and healthcare professionals: Keppra®, Vimpat® and Briviact®. In 2018 UCB also acquired the rights for nasal administration of midazolam, a treatment for acute repetitive seizures currently under review by the FDA.
However, therapies of epilepsy only target the symptoms of the disease and leave 30% of all patients with uncontrolled seizures4. This emphasizes a need for identifying new treatments that can prevent or cure epilepsy – a journey UCB has already embarked on and is looking to pioneer!
Here are the major milestones we reached or plan to reach:
Grow & Prepare
- approval in epilepsy POS – adjunctive therapy (Japan – 2016 / China – 2018)
- approval in epilepsy POS monotherapy (EU – 2016 / Japan – 2017)
- approval in epilepsy POS pediatric (U.S. & EU – 2017)
- start of Phase 3 in epilepsy PGTCS (2015)
- approval in epilepsy POS monotherapy (Japan – 2015 / China – 2018)
- approval in epilepsy PGTCS – adjunctive therapy (Japan – 2016 / China – 2018)
- approval in epilepsy POS (U.S. & EU – 2016)
- approval in epilepsy POS monotherapy (U.S. – 2017)
- approval in epilepsy POS pediatric (U.S. & EU – 2018)
- acquisition and filing (U.S. – 2018)
Accelerate & Expand
- approval in epilepsy POS pediatric (Japan – Jan 2019)
- Phase 3 results in epilepsy PGTCS (mid 2019)
- filing in epilepsy monotherapy (U.S. - Jan 2019)
- patent expiry (Japan – 2020)
- Phase 3 start in acute repetitive seizures (2020)
- Phase 3 results in epilepsy POS (Japan – 2021)
- regulatory decision in acute repetitive seizure (U.S. – Q2 2019)
- Phase 3 start (2019)
- Phase 2b results in drug resistant epilepsy (H1 2020)
Breakthrough & Lead
- patent expiry (U.S. & EU – 2022)
- loss of exclusivity (Japan – 2024)
- patent expiry (U.S. & EU – 2026)
Please refer to UCB website for more information about Vimpat®, Keppra® and Briviact® approved indications.