Drug Overview
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.
Analyst Outlook
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.
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.
Analyst Outlook
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.
Table of Contents
OVERVIEW- Drug Overview
- Product Profiles
- Fetzima: Depression
LIST OF FIGURES
Figure 1: The author's drug assessment summary of Fetzima for depression
Figure 2: The author's drug assessment summary of Fetzima for depression
Figure 3: Fetzima sales for depression in the US, 2017–26
LIST OF TABLES
Table 1: Fetzima drug profile
Table 2: Approval history of Fetzima for depression in the US
Table 3: Late-phase trials of Fetzima for depression
Table 4: Fetzima ongoing Phase III trials in depression
Table 5: Fetzima for depression – SWOT analysis
