Marinus’ Ztalmy (ganaxolone) Receives EC’s Approval for Adjunctive Treatment of Epileptic Seizures Associated with CDKL5 Deficiency Disorder
Shots:
- The EC has approved Ztalmy oral suspension for adjunctive treatment of epileptic seizures associated with CDKL5 deficiency disorder (CDD) in patients aged 2-17yrs.
- The approval was based on the P-III trial (Marigold) evaluating Ztalmy, a neuroactive steroid GABAA receptor modulator in 101 patients. The trial met the 1EPs & showed a 30.7% median reduction in 28-day major motor seizure frequency over 6.9% in PBO
- In the (Marigold) OLE study, patients experienced a median 49.6% reduction in major motor seizure frequency for 12mos. & showed efficacy, safety & tolerability with the most common adverse reactions & the results were published in The Lancet Neurology
Ref: Businesswire | Image: Marinus
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