U.S. FDA Approves Diacomit for the Treatment of Seizures in Patients with Dravet Syndrome Taking Clobazam
Germantown, MD, USA (August 31, 2018) – Amarex Clinical Research, LLC announces today that, on August 20, 2018, the U.S. FDA approved Diacomit for the treatment of seizures in patients with Dravet Syndrome 2 years of age and older taking clobazam. Diacomit (stiripentol) is an anticonvulsant drug developed by Biocodex SAS, a multinational pharmaceutical company headquartered in France that centers on CNS and gastroenterology R&D. Diacomit has already obtained approval in 29 countries and received an orphan-drug designation (ODD) from the U.S. FDA in 2008. Amarex provided statistical and regulatory services that supported US FDA approval.
Amarex’s statistics department prepared an integrated summary of safety and effectiveness (ISS/ISE), converted all clinical trial data into CDISC format, and provided the statistical analyses that established the effectiveness of stiripentol for the treatment of seizures associated with Dravet Syndrome. Amarex’s regulatory affairs department successfully compiled and submitted the New Drug Application (NDA) to the U.S. FDA via electronic submission, following ICH guidelines for electronic Common Technical Document (eCTD) formatting and hyperlinking.
Amarex’s President and CEO, Dr. Kazem Kazempour, congratulated Biocodex saying: “After many years of hard work, we are pleased that the FDA has accepted and approved this drug for sale in the U.S. Our statistical and regulatory teams put in a lot of time and energy on this project. We enjoyed working with Biocodex, and it is wonderful news to the parents of children affected by this disease that they now have a new option to help treat their children.”
About Amarex Clinical Research
Amarex is a global, full service Contract Research Organization (CRO), whose leadership team has significant expertise conducting biomedical research, and whose combined experience includes the design and conduct of several hundred clinical research projects in many therapeutic indications. Amarex provides comprehensive services in Project Management (Phase I-IV, BE/BA, PK/PD), Regulatory Affairs, FDA Applications and Submissions, Applications and Submissions to international Health Authorities, GxP Compliance Audits, Clinical Operations, Adaptive Study Designs, Statistical Analysis, Data Management and General Consulting. Amarex has taken clients’ products through the entire approval process from writing the initial product approval strategy to the marketing approval application with a growing list of approved products. Amarex is committed to cost effective, high quality clinical product development.
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