
DIACOMIT® is an original anti‑epileptic drug resulting from BIOCODEX’s research program.2,3 Its chemical structure is not related to any other known anticonvulsant and its active substance is stiripentol.4
DIACOMIT® is to be used as an add‑on therapy to clobazam for seizures associated with Dravet syndrome when these are not adequately controlled.1
FDA approved in August 2018 after 18 years of compassionate use for Dravet syndrome1,5
DIACOMIT® was designated as an orphan drug by the European Medicines Agency (EMA) for use in severe myoclonic epilepsy in infancy (SMEI)6
Conditional marketing authorization was granted for Europe6
DIACOMIT® was designated as an orphan medicine in the US7
Marketing authorization was granted for Japan8
Marketing authorization was granted for Canada9,10
Conditional approval was switched to full European marketing authorization for use in conjunction with valproate and clobazam as adjunctive therapy of refractory generalized tonic-clonic seizures in patients with SMEI/Dravet syndrome whose seizures are not adequately controlled with clobazam and valproate alone6
FDA approval was granted for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam11
1. DIACOMIT® (stiripentol) prescribing information. Beauvais, France: BIOCODEX; 2018. 2. European Medicines Agency. EPAR – Scientific Discussion: Diacomit. Published 2007. https://www.ema.europa.eu/en/documents/scientific-discussion/diacomit-epar-scientific-discussion_en.pdf. Accessed March 12, 2019. 3. Brigo F, Igwe SC, Bragazzi NL. Antiepileptic drugs for the treatment of infants with severe myoclonic epilepsy. Cochrane Database Syst Rev. 2017;5:CD010483. doi:10.1002/14651858.CD010483.pub4. 4. US Food and Drug Administration. Center for Drug Evaluation and Research Clinical Review: DIACOMIT, stiripentol. August 2018. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2018/206709Orig1s000,207223Orig1s000MedR.pdf. Accessed March 12, 2019. 5. Data on file, BIOCODEX; 2019. 6. European Medicines Agency. EPAR summary for the public. Diacomit. https://www.ema.europa.eu/documents/overview/diacomit-epar-summary-public_en.pdf. Updated June 2014. Accessed March 12, 2019. 7. US Food and Drug Administration. Search orphan drug designations and approvals. https://www.accessdata.fda.gov/scripts/opdlisting/oopd/detailedIndex.cfm?cfgridkey=266108. Accessed March 12, 2019. 8. Pharmaceuticals and Medical Devices Agency. New drugs approved in FY 2012. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html. Accessed March 12, 2019. 9. Canadian Agency for Drugs and Technologies in Health. Common Drug Review: Clinical Review Report on Diacomit (stiripentol). https://www.cadth.ca/sites/default/files/cdr/clinical/sr0360_diacomit_cl_report.pdf. Accessed March 12, 2019. 10. Government of Canada. Summary Basis of Decision - Diacomit - Health Canada. Published February 21, 2013. https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?lang=en&linkID=SBD00181. Accessed March 12, 2019. 11. US Food and Drug Administration. Drug Trial Snapshot: DIACOMIT. https://www.fda.gov/Drugs/InformationOnDrugs/ucm618455.htm. Accessed March 12, 2019.