Marinus Pharma Says Ganaxolone To Treat Seizures Associated With CDD Approved In China

(RTTNews) - Marinus Pharmaceuticals, Inc. (MRNS) Thursday said the China National Medical Products Administration (NMPA) has approved ganaxolone for the treatment of epileptic seizures in patients two years of age and older with CDKL5 deficiency disorder (CDD).

CDD is a genetic disorder characterized by seizures beginning in infancy with severe neurodevelopmental impairment.

In 2022, Tenacia Biotechnology had secured rights to develop and commercialize ganaxolone in China, Hong Kong, Macau and Taiwan. In return Marinus will receive royalties and other milestone payments.

The approval is supported by data from Marinus' Phase 3 Marigold trial in CDD. In the study, patients treated with ganaxolone showed a 30.7 percent median reduction in 28-day major motor seizure frequency, compared to a 6.9 percent reduction for those receiving placebo, achieving the trial's primary endpoint.

Ganaxolone is already approved in the U.S., and European Union to treat seizures associated with CDD.