3 January 2016 - The TGA rejects the registration dossier for Pierre Fabre's serotonin noradrenaline reuptake inhibitor (SNRI).

The TGA has published an AusPAR for Fetzima (levomilnacipran hydrochloride) which states that the submission was rejected in July last year. Pierre Fabre was seeking the registration of Fetzima for the treatment of major depressive disorder.

While the pivotal short term studies demonstrated a statistically significant improvement in measures of depression when compared with placebo treatment, none of these studies in the submission had an active control arm. The TGA adopted EMA guideline states that the dossier should include parallel group studies against placebo and active comparator (generally accepted standard treatment). Three-arm or multi-arm studies are strongly recommended for pivotal studies in Phase III of development, as the trials will be internally validated and the problem of assay sensitivity can be addressed. The Delegate was not satisfied that the pivotal studies have internal validity and therefore the results may not be clinically meaningful.

Fetzima is registered in the US and Canada but not in Europe.

Read TGA AusPAR for Fetzima