The European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a new indication for Fintepla (fenfluramine).
Fintepla was indicated for the treatment of seizures associated with Dravet syndrome and now it will also be indicated for the treatment of seizures associated with Lennox-Gastaut syndrome as an add-on therapy to other anti-epileptic medicines for patients 2 years of age and older.
Detailed recommendations for the use of this product will be described in the updated summary of product characteristics (SmPC), which will be published in the revised European public assessment report (EPAR) and will be available in all official European Union languages after a decision on this change to the marketing authorisation has been granted by the European Commission.
More information is available here.