Ztalmy approved by EC for seizures associated with CDKL5 deficiency

31 July 2023

The European Commission has granted marketing authorization in the European Union (EU) for Ztalmy (ganaxolone) oral suspension.

Ztalmy is indicated 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.

Ganaxolone is developed by USA-based Marinus Pharmaceuticals (Nasdaq: MRNS), whose shares edged up 1.6% to $10.29.

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