The U.S. Food and Drug Administration has approved Marinus Pharmaceuticals Inc’s lead drug to treat seizures associated with a rare genetic disorder in patients two years of age and older, the company said on Friday.
The regulatory approval was based on data from a late-stage study in 101 patients that showed a 30.7% median reduction in 28-day major motor seizure frequency in patients treated with the drug, as compared to a 6.9% decline in those receiving placebo.
Marinus has priced the drug at about $133,000 per patient per year at the wholesale level, while after discounts, including for Medicaid patients, it will cost an average of $105,000 per patient per year, Chief Executive Officer Scott Braunstein told Reuters.
At the wholesale level, the chronic medication translates to $2,425 per bottle, Braunstein said.
Ztalmy is expected to be commercially available in the U.S. in July through a designated specialty pharmacy.