Marinus Pharmaceuticals, Inc.’s Ztalmy (ganaxolone) won European Commission approval in July 2023 as an oral treatment for seizures associated with a rare, genetic pediatric-onset epilepsy disorder. The drug was previously approved by the US FDA in March 2022, which marked an important moment for the company, as the drug had previously failed in clinical trials for Fragile X syndrome and post-partum depression.
Ztalmy, a positive allosteric modulator of the GABAA receptor for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder in patients two years of age and older, is expected to see worldwide sales of around $182m in 2028, according to Evaluate Pharma
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