FDA Approves New Therapy for Dravet Syndrome
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U.S. Food and Drug Administration approved Fintepla (fenfluramine), a Schedule IV controlled substance, for the treatment of seizures associated with Dravet syndrome in patients age 2 and older.

• Dravet syndrome is a life-threatening, rare, and chronic form of epilepsy. It is often characterized by severe and unrelenting seizures despite medical treatment.

• Fintepla labeling includes a boxed warning stating the drug is associated with valvular heart disease (VHD) and pulmonary arterial hypertension (PAH).

• Because of these risks, patients must have cardiac monitoring using echocardiograms performed before treatment, every six months during treatment, and once three to six months after treatment is discontinued.

• The most common adverse reactions in clinical studies were decreased appetite; drowsiness, sedation, and lethargy; diarrhea; constipation; abnormal echocardiogram; fatigue; ataxia, balance disorder, gait disturbance; increased blood pressure; drooling, salivary hypersecretion; pyrexia; upper respiratory tract infection; vomiting; decreased weight; risk of falls; and status epilepticus.

• The FDA granted this application Priority Review. Fintepla received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases.

• The FDA granted approval of Fintepla to Zogenix, Inc.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-new-therapy-dravet-syndrome
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