Biocodex gets FDA nod for Diacomit
Biocodex has received the FDA nod for Diacomit (stiripentol) for the treatment of seizures associated with Dravet syndrome in patients 2 years of age and older taking clobazam.
Dravet syndrome, also known as severe myoclonic epilepsy in infancy is a catastrophic early onset epileptic syndrome that affects approximately 2,000 to 8,000 patients in the United States.
Dravet syndrome is characterized by severe epilepsy, psychomotor retardation, and often ataxia. In most cases, the first seizures occur during the first year of life. Status epilepticus is frequent and is thought to be in part responsible for the high mortality rate reported in these patients, ranging from 15.9 to 18%.
"The FDA's approval of Diacomit is a major milestone for Biocodex. It recognizes our R&D excellence in developing therapies for Dravet syndrome and brings a new treatment option to young patients in the USA," Biocodex president and CEO Jean-Marie Lefevre said, in a statement. "Diacomit is the result of Biocodex's own research and has been the subject of substantial investment. Our research work, along with the pre-clinical and clinical studies carried out in close collaboration with teams of university experts from around the world, have enabled us to obtain approval in Europe, Japan, Canada and, as of now, in the United States. Our efforts will not stop there. We are continuing our research on stiripentol in order to do everything in our power to improve treatment for children and adults suffering from pharmacoresistant epilepsy."
Dravet syndrome, also known as severe myoclonic epilepsy in infancy is a catastrophic early onset epileptic syndrome that affects approximately 2,000 to 8,000 patients in the United States.
Dravet syndrome is characterized by severe epilepsy, psychomotor retardation, and often ataxia. In most cases, the first seizures occur during the first year of life. Status epilepticus is frequent and is thought to be in part responsible for the high mortality rate reported in these patients, ranging from 15.9 to 18%.
"The FDA's approval of Diacomit is a major milestone for Biocodex. It recognizes our R&D excellence in developing therapies for Dravet syndrome and brings a new treatment option to young patients in the USA," Biocodex president and CEO Jean-Marie Lefevre said, in a statement. "Diacomit is the result of Biocodex's own research and has been the subject of substantial investment. Our research work, along with the pre-clinical and clinical studies carried out in close collaboration with teams of university experts from around the world, have enabled us to obtain approval in Europe, Japan, Canada and, as of now, in the United States. Our efforts will not stop there. We are continuing our research on stiripentol in order to do everything in our power to improve treatment for children and adults suffering from pharmacoresistant epilepsy."