Brad Chapman, Head of US Epilepsy and Rare Syndromes at UCB, discusses the recent decision by the US Drug Enforcement Agency (DEA) to deschedule fenfluramine.
In 2020, the FDA approved Fenfluramine as a serotonin agonist for the treatment of seizures caused by Dravet syndrome, and in 2022, by Lennox-Gastaut syndrome. The DEA listed fenfluramine as a schedule IV controlled substance in 1973 when it was used as a part of a weight loss therapy (PhenFen).
Dravet syndrome is a rare neurological condition that usually appears during the first year of life as frequent febrile seizures. As the condition progresses, other types of seizures usually occur, including myoclonus and status epilepticus. Typically, moderate to severe cognitive impairment is common.
Defined as a rare neurological condition, individuals with Lennox-Gastaut syndrome experience multiple types of seizures and intellectual disability. Various factors can cause this condition, such as:
- brain malformations
- perinatal asphyxia
- severe head injury
- central nervous system infection
- inherited degenerative or metabolic conditions.
No cause can be found in approximately one-third of cases.
As noted by Mr. Chapman, descheduling fenfluramine can help both the Dravet and Lennox-Gastaut populations obtain this medication more easily and reduce unnecessary burden on the family.
Rystiggo (rozanolixizumab-noli) was approved by the U.S. FDA on June 27, 2023.
To learn more about these and other rare neurological disorders, go to checkrare.com/diseases/neurology /