Mar­i­nus com­pletes its turn­around with first ap­proval of sole drug, win­ning a PRV for its ef­forts

Af­ter a long and wind­ing road, Mar­i­nus Phar­ma­ceu­ti­cals has achieved FDA ap­proval for its sole drug.

The biotech an­nounced Fri­day af­ter­noon that reg­u­la­tors OK’d ganax­olone for the treat­ment of seizures as­so­ci­at­ed with CD­KL5 de­fi­cien­cy dis­or­der, or CDD, in pa­tients two years and old­er. Mar­i­nus plans to mar­ket the drug as Ztalmy and will come with an av­er­age an­nu­al whole­sale ac­qui­si­tion cost of about $133,000, based on the ex­pec­ta­tion that an av­er­age pa­tient will be four and a half years old and weigh 16 kilo­grams, a com­pa­ny spokesper­son told End­points News.

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