• Accelerated pathway underscores urgent need for innovative solutions for patients with devastating, childhood-onset epilepsies
• Novel 5HT2C mechanism designed to reduce drug-resistant seizures in children and adults living with Developmental Epileptic Encephalopathies (DEEs) and improve quality of life for patients and their caregivers¹
• Dual Breakthrough Therapy Designation (BTD) in China and the U.S. underscores Lundbeck's mission to advance brain health and transform lives of patients with rare neurological diseases

Lundbeck announced that its investigational drug bexicaserin, for the treatment of seizures associated with Developmental and Epileptic Encephalopathies (DEEs), has been granted Breakthrough Therapy Designation (BTD) by China's Center for Drug Evaluation (CDE).

DEEs are a heterogeneous group of severe, childhood-onset, rare epilepsies marked by drug-resistant seizures and developmental stagnation or regression.² Affecting more than 1 in 2,000 live births, DEEs carry a mortality rate of 17–50%.³ Survivors are often left with profound neurological disabilities, creating a heavy burden for families and society and underscoring the urgent need for new treatment options.⁴

"We are honored that bexicaserin has been granted Breakthrough Therapy Designation, recognizing the potential of our innovative approach to advancing treatment in one of the most challenging areas of epilepsy," said Johan Luthman, EVP and Head of Research & Development at Lundbeck. "Drawing on our expertise in neuroscience, and past experiences with epilepsy therapies, we are deeply committed driving the global Phase 3 clinical program forward. Obtaining BTD for the program in China supports us in bringing Bexicaserin to patients living with DEEs as quickly as possible."

Bexicaserin (LP352) is a novel investigational, oral therapy that selectively targets the 5-HT2C receptor while avoiding activity at the 5-HT2B and 5-HT2A subtypes, a profile designed to reduce cardiovascular risk. The medicine has also been granted BTD by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with DEEs.

"Bexicaserin's Breakthrough Therapy Designation is an important step forward for Lundbeck in China and reflects our dedication to addressing the urgent needs of patients living with DEEs," said Zhang Yifan, Managing Director of Lundbeck China. "This recognition strengthens our commitment to bringing innovative neuroscience solutions to China, working hand in hand with partners to advance brain health and improve the lives of patients and their families."

The BTD procedure is designed to accelerate the development and review of innovative medicines for serious or life-threatening diseases with no adequate treatment options, or where early evidence shows substantial advantages over existing therapies. The CDE prioritizes resource allocation, communication, enhanced guidance, and development promotion for drugs included in the BTD drug procedure.