UCB Epilepsy Drug Study Meets Endpoints In Japan, China
By Lori Clapper
UCB recently announced that its Phase 3 clinical study of seizure med Vimpat (lacosamide) in Japanese and Chinese adult patients has proven the drug’s efficacy at reducing frequency of partial-onset seizures when compared to a placebo.
Because of the research’s success, UCB anticipates it will submit regulatory applications for Vimpat in both Japan and China in 2015.
This Phase 3 multicenter, double-blind, randomized, placebo-controlled, parallel-group study assessed safety and efficacy of both 200 and 400 mg/day dosages of Vimpat in 547 patients between the ages of 16 to 70 years of age. The expected result was to measure the change in partial-onset seizure frequency per 28 days from baseline to the maintenance period.
Epilepsy is a disease of the brain that affects around 65 million people worldwide.
Professor Dr. Iris Loew Friedrich, CMO and EVP of UCB, said the biopharm’s goal for Vimpat is to ensure patients with partial-onset seizures, as part of epilepsy, have ready access to proper treatment around the world.
“To date, Vimpat is available in over 40 countries and has been used by over 300,000 patients,” Friedrich added. “The data from this study…represents a significant milestone for the epilepsy community and ultimately for patients.
UCB first launched Vimpat in the European Union in September 2008 as adjunctive therapy to treat partial-onset seizures. The company also has rights to the drug in Japan as of the end of 2010, along with global rights to development and marketing. However, Vimpat has not received Japanese or Chinese approval to treat epilepsy.