FDA ap­provals roundup: Zo­genix's Fin­tepla, Ul­tragenyx's Do­jolvi, and Genen­tech's Ph­es­go

A week­ly up­date on new drug ap­provals and in­di­ca­tions from the FDA:

New ap­provals

Fin­tepla gets the go-ahead for Dravet syn­drome

Zo­genix’s Fin­tepla (fen­flu­ramine) has been ap­proved for the treat­ment of seizures as­so­ci­at­ed with Dravet syn­drome in pa­tients aged 2 years or old­er. The syn­drome is a rare, life-threat­en­ing form of epilep­sy.

The ap­proval was based on find­ings from two clin­i­cal stud­ies in 202 par­tic­i­pants aged be­tween 2 and 18 years, in which the change from base­line in fre­quen­cy of con­vul­sive seizures was mea­sured. In both stud­ies, chil­dren who re­ceived Fin­tepla had sig­nif­i­cant­ly greater re­duc­tions in the fre­quen­cy of con­vul­sive seizures, com­pared with those re­ceiv­ing place­bo. The re­duc­tions were seen with­in 3-4 weeks of ther­a­py ini­ti­a­tion and re­mained gen­er­al­ly con­sis­tent dur­ing the treat­ment pe­ri­ods of 14-15 weeks.

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