Posted by Michael Wonder on 29 May 2023
Marinus Pharmaceuticals receives positive CHMP opinion for Ztalmy (ganaxolone) for the adjunctive treatment of seizures associated with CDKL5 deficiency disorder
26 May 2023 - The European Commission decision is expected within 67 days of the CHMP opinion.
Marinus Pharmaceuticals today announced that the CHMP of the EMA has adopted a positive opinion recommending the approval of Ztalmy (ganaxolone) oral suspension for the adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 deficiency disorder in patients two to 17 years of age.
