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Marinus’ Ztalmy (ganaxolone) Receives the US FDA’s Approval for the Treatment of CDKL5 Deficiency Disorder

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Marinus’ Ztalmy (ganaxolone) Receives the US FDA’s Approval for the Treatment of CDKL5 Deficiency Disorder

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

Click here to­ read the full press release 

Neha

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

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