Fetzima (levomilnacipran; Allergan) is a serotonin-norepinephrine reuptake inhibitor indicated for the treatment of major depressive disorder (MDD) in the US. The active molecule, levomilnacipran, is an enantiomer of milnacipran, a racemic mixture originally developed by Pierre Fabre. Milnacipran is currently approved for the treatment of MDD in France and Japan, and while milnacipran is not approved for depression in the US, Allergan markets the drug for the treatment of fibromyalgia under the brand name Savella. The US Food and Drug Administration approved Fetzima for the treatment of MDD in the US in July 2013.
Forest Laboratories acquired the rights to develop and commercialize Fetzima in December 2008, when it paid Pierre Fabre an upfront fee of $75m plus undisclosed milestone payments. Allergan added Fetzima to its portfolio upon the 2014 acquisition of the central nervous system-focused Forest for $25bn.
Although Fetzima (levomilnacipran; Allergan) possesses the advantage of a long patent life over most other branded antidepressants, the product is forecast to exhibit unremarkable growth over the 10-year period, in line with its slow performance thus far. Late market entry and a lack of differentiation in the serotonin-norepinephrine reuptake inhibitor (SNRI) class will ultimately limit Fetzima’s opportunity. The drug has a “me-too” clinical profile compared to established SNRI therapies such as Effexor (venlafaxine; Pfizer), Cymbalta (duloxetine; Eli Lilly/Shionogi), Pristiq (desvenlafaxine; Pfizer/Laboratorios Servier), and Savella (milnacipran; Allergan/Asahi Kasei Pharma/Pierre Fabre), of which there are cheap generic versions available. Since Allergan has not indicated any plans or Fetzima’s expanded development that would sufficiently distinguish the product from competitors, the drug will continue to blend in with the plethora of available antidepressants in the US market.
LIST OF FIGURES
12 Figure 1: Datamonitor Healthcare’s drug assessment summary of Fetzima for depression
13 Figure 2: Datamonitor Healthcare’s drug assessment summary of Fetzima for depression
15 Figure 3: Fetzima sales for depression in the US, 2017–26
LIST OF TABLES
5 Table 1: Fetzima drug profile
6 Table 2: Approval history of Fetzima for depression in the US
7 Table 3: Late-phase trials of Fetzima for depression
10 Table 4: Fetzima ongoing Phase III trials in depression
11 Table 5: Fetzima for depression – SWOT analysis
This is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.