U.S. FDA approves Marinus Pharma’s drug to treat seizures; shares jump
March 18 (Reuters) – The U.S. health regulator has approved Marinus Pharmaceuticals Inc’s (MRNS.O) lead drug to treat seizures associated with a rare genetic disorder in patients two years of age and older, the company said on Friday, sending its shares soaring around 36%.The oral drug, which will be sold under the brand name Ztalmy, is for treatment of seizures associated with CDKL5 deficiency disorder, a rare genetic epilepsy.Ztalmy is expected to be commercially available in the United States in July following scheduling by the U.S. Drug Enforcement Administration, Marinus said in a statement.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.Cowen and Co analyst Joseph Thome expects the drug to garner peak sales of $71 million in the U.S. in 2029 for the treatment of CDKL5 deficiency disorder.Ztalmy exhibits anti-seizure and anti-anxiety activity by affecting a type of protein in the central nervous system called GABAA receptor.The approval by the Food and Drug Administration 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.
