FDA approves Ztalmy, first treatment specifically for CDD

19 March 2022

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.

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