RADNOR, PA — Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS) has announced that China’s National Medical Products Administration (NMPA) has approved its ganaxolone oral suspension. This drug targets epileptic seizures in patients aged two years and older who suffer from CDKL5 deficiency disorder (CDD).
Marinus entered a collaboration with Tenacia Biotechnology in November 2022. This agreement allows Tenacia to develop and commercialize ganaxolone in several regions, including Mainland China, Hong Kong, Macau, and Taiwan. In return, Marinus receives royalties and milestone payments based on sales and regulatory achievements.
“CDD is a severe and rapidly progressive neurodevelopmental disorder and before ganaxolone, there had been no treatments approved for this condition in China,” said Dr. Xiaoxiang Chen, CEO of Tenacia Biotechnology. “There is an urgent need to bring innovative new therapies to patients and families living with CDD, particularly as diagnosis rates continue to rise.”
The approval follows data from Marinus’ Phase 3 Marigold trial. This double-blind, placebo-controlled study involved 101 patients. Those treated with ganaxolone experienced a 30.7% median reduction in major motor seizure frequency over 28 days, compared to a 6.9% reduction in the placebo group. The trial’s primary endpoint was achieved with statistical significance (p=0.0036). Patients on ganaxolone for at least 12 months in an open-label extension study saw a median 49.6% reduction in seizure frequency. The drug was generally well-tolerated, with somnolence being the most common side effect.
“CDD brings unpredictability and increased healthcare needs and costs to patients and their families, and can significantly impact their quality of life,” said Kimberly McCormick, PharmD., Chief Regulatory and Quality Assurance Officer of Marinus. “The approval in China represents an important step forward for patients living with CDD and underscores our commitment to bringing innovative medicines to people living with rare genetic epilepsies across the globe.”
Ganaxolone is already approved in the U.S. and European Union for certain patients with CDD. Marinus supplies ganaxolone to all global markets under its collaboration agreements.
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