Biocodex's Diacomit (stiripentol) Receives FDA Approval for Seizures Associated with Dravet Syndrome (DS) in Patients Aged 2 Years or Older
Shots:
- The approval is based on two study STICLO France and STICLO Italy assessing Diacomit vs PBO in patients with Dravet Syndrome aged 2 years of age and older taking clobazam
- STICLO France and STICLO Italy study results: responder rate (71%- 67% vs 5%- 9.1%)
- Diacomit 250mg & 500mg (stiripentol) is an anti-convulsant drug- approved as an adjunctive treatment with clobazam and valproate DS in 27 countries including EU- Canada- Japan in Jan 2007- Dec 2012- Sept 2012 respectively
Ref: PRNewsWire | Image: Twitter
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