Browsed by
Tag: Receives

Xenon Pharmaceuticals Receives FDA Feedback and is on Track to Initiate XEN496 Phase 3 Clinical …

Xenon Pharmaceuticals Receives FDA Feedback and is on Track to Initiate XEN496 Phase 3 Clinical …

BURNABY, British Columbia, Oct. 08, 2020 (GLOBE NEWSWIRE) — Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a neurology-focused biopharmaceutical company, today provided regulatory updates on its proprietary pediatric neurology program, XEN496, a Kv7 potassium channel modulator that is a proprietary pediatric formulation of the active ingredient ezogabine being developed for the treatment of KCNQ2 developmental and epileptic encephalopathy (KCNQ2-DEE). With the U.S. Food and Drug Administration (FDA) having completed its review of the clinical trial protocol, Xenon is on track to initiate the XEN496 Phase 3 clinical trial in pediatric patients with KCNQ2-DEE before year-end.

In addition, Xenon has received a positive opinion from the Committee for Orphan Medicinal Products (COMP) of the European Medicines Agency (EMA), which recommends the granting of an orphan medicinal product designation for XEN496 for the treatment of KCNQ2-DEE. This European designation is in addition to the FDA granting Fast Track designation for XEN496 for the treatment of seizures associated with KCNQ2-DEE as well as Orphan Drug Designation (ODD) for the treatment of KCNQ2-DEE.

Dr. Simon Pimstone, Xenon’s Chief Executive Officer, said, “This marks an extremely important milestone for Xenon, with the first of our proprietary product candidates now poised to enter a pivotal Phase 3 clinical trial. With feedback from the FDA, pharmacokinetic data supportive of our proprietary pediatric formulation, and considerable progress made in site selection and other preparations, we are excited to move forward with our ‘EPIK’ Phase 3 clinical trial studying XEN496 in pediatric patients with KCNQ2-DEE. In addition, receiving an orphan medicinal product designation for XEN496 in Europe underscores that KCNQ2-DEE is a severe, early onset epilepsy disorder and further validates Xenon’s novel, ‘precision medicine’ approach to develop treatments for pediatric epilepsies. We continue to work closely with the medical community, genetic testing companies, and patient advocacy groups to identify potential patients for

Read the rest