FDA Approves Expanded Indication for Use of Stiripentol for Dravet Syndrome in Children Age 6 Months or More

The Food and Drug Administration (FDA) has approved stiripentol (Diacomit; Biocodex, San Mateo, CA) for the treatment of seizures associated with Dravet Syndrome in patients 6 months of age and older, weighing 15 lbs or more and taking clobazam.

In 2 clinical studies, the drug reduced generalized clonic or tonic-clonic seizures by a median 84% compared with 5.8% on placebo after 2 months. There are no clinical data to support the use of Diacomit as monotherapy for Dravet syndrome.

“We are thrilled to positively impact more children’s lives by providing access to specialized, effective treatment closer to the time of their Dravet syndrome diagnosis,” said Nicolas Coudurier, chief executive officer, Biocodex. 

Stiripentol first received FDA approval in 2018 for children 2 years of age and older.