The EMA’s CHMP has adopted a positive opinion recommending the approval of Ztalmy oral suspension for epileptic seizures associated with CDD in patients aged 2-17yrs.
The application was based on the P-III (Marigold) trial evaluating Ztalmy vs PBO in 101 patients. The trial met its 1EPs & showed a median 30.7% vs 6.9% reduction in 28-day major motor seizure frequency. In the (Marigold) OLE study, a median 49.6% reduction in major motor seizure frequency for 12mos. & demonstrated efficacy, safety & tolerability
The EC’s final decision is expected within 67 days of receipt of the CHMP opinion & will be valid to all 27 EU member states, Iceland, Norway & Liechtenstein. If Ztalmy is approved, it will be 1st treatment in the EU & will be commercialized by Orion
Ref: Marinus | Image: Marinus
Related News:- Marinus’ Ztalmy (ganaxolone) Receives the US FDA’s Approval for the Treatment of CDKL5 Deficiency Disorder
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