28 January 2019 - FDA grants rare paediatric disease designation to XEN007 for alternating hemiplegia of childhood.

Xenon Pharmaceuticals today provided regulatory updates on XEN007 and XEN1101, two therapeutic candidates from its CNS pipeline.

The U.S. FDA has granted rare paediatric disease designation for the treatment of alternating hemiplegia of childhood with XEN007 (active ingredient flunarizine).  The designation allows recipient companies, upon approval of the subject treatment, to be eligible for a priority review voucher, which may be used to obtain what is referred to as priority review for a future submission of a new drug application.