Dual Breakthrough Therapy Designation in China and US for bexicaserin for the treatment of seizures in severe rare epilepsies

An investigational drug, bexicaserin has been granted Breakthrough Therapy Designation (BTD) by China’s Center for Drug Evaluation. The medicine has also been granted BTD by the U.S. Food and Drug Administration (FDA) for the treatment of seizures associated with severe, childhood-onset rare epilepsies

‘Breakthrough Therapy Designation’ (BTD)is a process that can be applied to speed up the development and review of drugs where the medication is intended to treat serious or life-threatening conditions. When preliminary findings show that a drug may demonstrate ‘substantial improvement’ for patients, a BTD means more resources are allocated into the development of the drug and it will be prioritised for review by the relevant regulatory authorities. 

In America, the Food and Drug Administration (FDA) is responsible for approving new medication. Even with a BTD a rigorous review will take place of all the phases of the clinical trial and in the UK, drugs must be approved for use by the MHRA. Where a drug has been approved by the FDA, through the International Regulation Procedure, the MHRA can licence a drug for use within 60 days. 

Further evidence must now be gathered within clinical trials and be reviewed by the FDA (and other equivalent regulatory agencies) before Lundbeck’s bexicaserin can be approved as a treatment. It is an oral therapy and designed to reduce cardiovascular risk.

Nicola Swanborough, Head of External Affairs at the Epilepsy Society commented: “Although the trials are taking place in China and USA, the Breakthrough Therapy Designation status is a significant step forwards. Data from the FDA shows that drugs with BTD status are approved 30% more quickly so this is positive news and we will continue to monitor its progress and hope that there will be positive news for patients and their families.”

More information about the approval and drug trial are available here: Lundbeck's bexicaserin receives Breakthrough Therapy Designation in China for the treatment of seizures in severe rare epilepsies