FDA Approves Ztalmy to Treat CDD-Related Seizures

The FDA has approved Marinus Pharmaceuticals’ Ztalmy (ganaxolone) for the treatment of seizures in patients with a rare pediatric disease, cyclin-dependent kinase-like 5 deficiency disorder (CDD).

The approval was supported by results from a phase 3 study in 101 patients, who were  randomized to receive either Ztalmy or placebo. Those who received the drug showed a reduction in the frequency of major seizures over 28 days.

The FDA previously granted Ztalmy Orphan Drug and Rare Pediatric Disease designations for the indication. Marinus Pharmaceuticals said the drug will be available in the U.S. market in July.