FDA supplemental approval for Diacomit to treat Dravet syndrome seizures in children as young as 6 months
Biocodex, Inc., a pharmaceutical company and manufacturer of Diacomit (stiripentol), announced that the FDA has approved Diacomit for the treatment of seizures associated with Dravet syndrome in patients 6 months and older, weighing 15 lb or more, and taking clobazam
The antiseizure treatment first received FDA approval in 2018 for children 2 years and older. Diacomit is now the only FDA-approved medication specifically indicated for Dravet syndrome seizures in children as young as 6 months. It is an effective treatment for seizures that are often resistant to other antiepileptic drugs. In two clinical studies, Diacomit reduced generalized clonic or tonic-clonic seizures by a median of 84% compared with 5.8% on placebo after two months..There are no clinical data to support the use of DiacomitT as monotherapy in Dravet syndrome.
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