Danish pharmaceutical company H. Lundbeck A/S (CPH:HLUN-A) announced on Monday 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).

The company says that 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 US Food and Drug Administration (FDA) for the treatment of seizures associated with DEEs.

This designation 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 prioritises resource allocation, communication, enhanced guidance, and development promotion for drugs included in the BTD drug procedure.

Bexicaserin is currently being evaluated in a global Phase 3 clinical programme.