The European Commission has granted marketing authorization in the European Union (EU) for Ztalmy (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age.

Ztalmy may be continued in patients 18 years of age and older. CDD is a serious and rare genetic disorder.

“Under a collaboration agreement Orion has the right to sell and market Ztalmy in Europe.”

Ganaxolone is developed by Marinus Pharmaceuticals, Inc. and under a collaboration agreement Orion has the right to sell and market Ztalmy in Europe. Following the European Commission approval, Orion is focusing on making Ztalmy available for patients in Europe and has pricing and reimbursement processes planned or underway in Europe.

Photo: Orion