In 2020, we continued to advance our leadership in epilepsy. UCB’s existing product portfolio for epilepsy symptom management includes Keppra®, Vimpat®, Briviact® and Nayzilam® (U.S. only).
Our ambition is to provide specific patient populations with epilepsy with a diverse set of differentiated medicine-based and technology-leveraged solutions. Through the experiences and outcomes we enable, we strive to offer patients freedom from their symptoms today and anti-epileptogenic options tomorrow, so each of them can live the life they want. Our recent acquisition of Engage Therapeutics, a clinical-stage pharmaceutical company developing Staccato®Alprazolam for the rapid termination of epileptic seizures, will further support these efforts.
Millions of people worldwide live with epilepsy , a condition characterized by recurring seizures. About half of people with newly-diagnosed epilepsy become seizure free with their first anti-epileptic drug, but approximately a third of people with epilepsy continue to live with uncontrolled seizures because there is no available treatment that fully works for them.
The aim of treatment is to enable patients to lead a life as normal as possible, free from seizures and with minimal or no side-effects, but the choice of treatment needs to be carefully tailored to each patient and their type of seizure. In the coming years it is our aim to improve the detection, management and treatment of epileptic seizures through an offering that integrates digital technology with patient input to guide clinical decisions.
We achieved a number of epilepsy-related milestones in 2020, all of which will allow us to continue delivering value to patients living with this condition and to advance solutions for unmet needs in the epilepsy community.
2020 saw the ongoing roll-out in the U.S. of Nayzilam® (midazolam) Nasal SprayCIV, the first nasal rescue treatment for epilepsy seizure clusters in the U.S.
In December, the Chinese Center for Drug Evaluation (CDE) approved the monotherapy indication in patients with partial onset seizures (POS) for Keppra® (levetiracetam) injection, for intravenous use.
In August, we shared results from our Phase 3 study for Vimpat® (lacosamide), which showed that adjunctive lacosamide treatment in patients 4 years and older with idiopathic generalized epilepsy resulted in a significantly lower risk of developing a second primary generalized tonic-clonic seizures and a significantly higher rate of freedom from these seizures.
In November, the U.S. Food and Drug Administration (FDA) approved Vimpat® as an adjunctive therapy in the treatment of primary generalized tonic-clonic seizures (PGTCS) in patients with epilepsy aged 4 years and above. These are the most serious seizures, posing a great risk to the health and wellbeing to patients suffering from them. The FDA also approved the use of Vimpat® IV in pediatric patients 4 years of age and above with partial onset seizures (POS) or primary generalized tonic-clonic seizures.
In December, the European Medicines Agency (EMA) and Japan’s Ministry of Health, Labor & Welfare (MHLW) approved Vimpat® as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in adults, adolescents and children from 4 years of age with idiopathic generalized epilepsy.
In March, UCB announced that the Phase 2b study of padsevonil in drug-resistant epilepsy patients failed to show any significant impact. While generally well-tolerated and safe, further analysis of the data led UCB to terminate the program as it did not offer sufficient benefit for people living with epilepsy over that provided by existing anti-epileptic treatments.
- 1 World Health Organization (WHO) Factsheet on Epilepsy, published on 20 June 2019, accessed on 30 November 2020 via https://www.who.int/en/news-room/fact-sheets/detail/epilepsy
- 2 Vossler DG, Knake S, O'Brien TJ On behalf of the SP0982 co-investigators, et alEfficacy and safety of adjunctive lacosamide in the treatment of primary generalised tonic-clonic seizures: a double-blind, randomised, placebo-controlled trialJournal of Neurology, Neurosurgery & Psychiatry 2020;91:1067-1075