Last Updated on December 31, 2023 by The Health Master
USFDA has approved Ztalmy (ganaxolone) to treat seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients 2 years of age and older.
USFDA approves drug for treatment of Seizures associated with rare disease
This is the first treatment for seizures associated with CDD and the first treatment specifically for CDD.
Disease or Condition
CDD is a rare developmental epileptic encephalopathy (dysfunction of the brain) caused by CDKL5 gene mutations.
The CDKL5 gene is responsible for making proteins that are important for normal brain functioning and development.
Effectiveness
The effectiveness of Ztalmy to treat seizures associated with CDD in patients 2 years of age and older was established in a double-blind, randomized, placebo-controlled study in participants aged 2 to 19 years of age.
Participants had confirmed CDKL5 gene mutations, seizures inadequately controlled by at least two previous treatment regimens, and a minimum average of 16 major motor (convulsive) seizures per 28 days during a two-month period prior to screening.
Safety Information
Ztalmy can cause somnolence (sleepiness) and sedation. These risks increase if patients use Ztalmy with central nervous system depressants, such as alcohol. Health care providers should monitor patients for suicidal behavior and thoughts.
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