Ashish Sagrolikar, Chief Commercial Officer of Zogenix, discusses the recent approval of Fintepla (fenfluramine) to reduce the frequency of seizures in Dravet patients 2 years of age or older.
Dravet syndrome, according to the NIH, is a severe form of epilepsy which typically appears in the first year of life. Over time, other seizures develop, making the disease difficult to treat.
The approval of fenfluramine was largely based on two clinical trials which included 202 subjects between the ages of 2 and 18. Both studies measured the change from baseline in the frequency of convulsive seizures and, in both studies, those treated with fenfluramine had a significant reduction in the frequency of convulsive seizures compared to those treated with placebo. As Mr. Sagrolikar says, these benefits were seen within a few weeks and continued throughout the 14- to 15-week treatment periods.
Fenfluramine is associated with valvular heart disease and pulmonary arterial hypertension, and due to these risks, the drug is available only through a restricted drug distribution program, under a risk evaluation and mitigation strategy.
For more information about Dravet syndrome and other rare nervous system disorders, visit checkrare.com/diseases/neurology-nervous-system-diseases/