FDA approves Ztalmy, first treatment specifically for CDD

The US Food and Drug Administration on Friday said it has approved Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two years of age and older.

Developed by USA-based rare seizure specialist Marinus Pharmaceuticals (Nasdaq: MRNS), this is the first treatment for seizures associated with CDD and the first treatment specifically for CDD. The news saw Marinus’ shares rocket almost 50% to $11.54.

The company said Ztalmy is expected to be commercially available in the USA in July following scheduling by the US Drug Enforcement Administration. Ztalmy has been priced at $2,425 per bottle, or $133,000 per year. With discounts, it will cost $105,000 per patient for a year’s treatment.