Ztalmy (ganaxolone oral suspension) — Medica
Seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder
Initial criteria
- Patient is age ≥ 2 years
- Patient has a molecularly confirmed pathogenic or likely pathogenic variant in the CDKL5 gene
- Patient has tried and/or is concomitantly receiving at least two other antiseizure medications (e.g., clobazam, Epidiolex [cannabidiol oral solution], lacosamide, lamotrigine, levetiracetam, phenobarbital, rufinamide, topiramate, valproate, vigabatrin, zonisamide)
- Medication is prescribed by or in consultation with a neurologist
Approval duration
1 year