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  • Fintepla gets orphan drug designation for Dravet syndrome
  • by Eo, Yun-Ho | translator Kim, Jung-Ju | Mar 21, 2024 05:52am
in Korea
MFDS has posted the designation of Fintepla as an orphan drug
Phase 3 clinical trial demonstrated efficacy of Fintepla in reducing seizures
 ¡ã UCB
'Fintepla' has been designated as an orphan drug in South Korea for its indication for Dravet syndrome.

The Ministry of Food and Drug Safety (MFDS) has announced this in the posting of the Orphan Drug Designation.

UCB¡¯s Fintepla (fenfluramine) initially acquired FDA approval for the treatment of rare epilepsy of infancy in 2020. Additionally, in 2022, it added an indication for Lennox-Gastaut syndrome (LGS).

Fenfluramine, banned in the United States in 1997, suppresses appetite by increasing serotonin content in the brain. It was discontinued because overuse of the drug led to the stimulation of the central nervous system, damaged heart valves, schizophrenic symptoms, and even death. Fenfluramine is current
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