Marinus’ Ztalmy (ganaxolone) Receives the US FDA’s Approval for the Treatment of CDKL5 Deficiency Disorder
Shots:
- The approval was based on the P-III (Marigold) trial evaluating Ztalmy vs PBO in 101 patients with CDD. The product is expected to be available in the US in July, following scheduling by the US DEA
- The trial meets its 1EPs i.e., reduction in 28-day major motor seizure frequency (30.7% vs 6.9%). In the (Marigold) OLE study, patients experienced a 49.6% reduction in major motor seizure frequency @12mos. & showed an efficacy, safety & tolerability
- The company is planning to launch ZTALMY One patient support program that enables the patients to access Ztalmy including assistance with product access, ongoing support to patients, caregivers & medical teams alongwith financial support
Ref: Marinus Pharmaceuticals | Image: Businesswire
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