Lundbeck’s Bexicaserin Receives Breakthrough Therapy Designation for Severe Epilepsies
Lundbeck has announced that its investigational drug bexicaserin has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation (CDE) for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs).
DEEs are a group of rare, severe childhood-onset epilepsies characterised by drug-resistant seizures and developmental delays or regression.
They affect more than 1 in 2,000 live births and carry a mortality rate of 17–50%. Survivors often experience significant neurological disabilities, creating a heavy burden on families and society.
Bexicaserin is an oral therapy that selectively targets the 5-HT2C receptor while avoiding 5-HT2B and 5-HT2A receptors, aiming to reduce cardiovascular risk.
The drug has also received Breakthrough Therapy Designation from the U.S. Food and Drug Administration for DEE-related seizures.
The BTD in China is designed to accelerate the development and review of medicines for serious or life-threatening conditions with limited treatment options.
It provides priority support, enhanced guidance, and faster communication with regulators to help bring innovative therapies to patients more quickly.
