Abilify/Abilify Maintena Drug Overview 2019

Report
62 Pages
March 2019
Region: Global
Citeline
ID: 4533533

Drug Overview
Abilify (aripiprazole; Otsuka/Lundbeck) is an atypical antipsychotic that contains aripiprazole, a partial agonist of dopamine receptor D2 and serotonin receptor 5-HT1A, and antagonist of the 5-HT2A receptor. Abilify’s partial agonist activity at the D2 receptors allows it to act as a dopamine stabilizer as it blocks overstimulated receptors and stimulates underactive ones. It is also thought to reduce the adverse events of stronger D2 blockade, particularly motor function side effects.

Market Snapshot

Otsuka Pharmaceutical initially launched Abilify in the US in 2002 for the treatment of schizophrenia, but the company subsequently pursued a number of bipolar disorder indications.
Abilify was originally co-marketed with Bristol-Myers Squibb. This agreement was terminated in the US in April 2015 and in the EU in June 2014. Otsuka Pharmaceutical is currently responsible for all marketing activities in the US and Japan. In the EU, the company marketed Abilify in partnership with Lundbeck for a period from 2013; however, this co-promotion is now limited to the long-acting injectable (LAI) formulation of aripiprazole.
Abilify Maintena is the LAI extension of the well-established Abilify franchise. While the product is related to the previous market leader Abilify, it does not match up to Abilify’s strong tolerability profile. Abilify Maintena is commonly associated with weight gain and akathisia, diminishing its clinical attractiveness.

OVERVIEW

Drug Overview
Product Profiles
Abilify: Depression
Abilify: Bipolar disorder
Abilify: Schizophrenia
Abilify Maintena: Bipolar disorder
Abilify Maintena: Schizophrenia

LIST OF FIGURES

Figure 1: The author's drug assessment summary of Abilify for depression
Figure 2: The author's drug assessment summary of Abilify for depression
Figure 3: Abilify sales for depression across the US, Japan, and five major EU markets, by country, 2017–26
Figure 4: Abilify for bipolar disorder – SWOT analysis
Figure 5: The author's drug assessment summary for Abilify in bipolar disorder
Figure 6: The author's drug assessment summary for Abilify in bipolar disorder
Figure 7: Abilify for schizophrenia – SWOT analysis
Figure 8: The author's drug assessment summary of Abilify for schizophrenia
Figure 9: The author's drug assessment summary of Abilify for schizophrenia
Figure 10: Abilify sales for schizophrenia across the US, Japan, and five major EU markets, by country, 2017–26
Figure 11: Abilify Maintena for bipolar disorder – SWOT analysis
Figure 12: The author's drug assessment summary for Abilify Maintena in bipolar disorder
Figure 13: The author's drug assessment summary for Abilify Maintena in bipolar disorder
Figure 14: Abilify Maintena for schizophrenia – SWOT analysis
Figure 15: The author's drug assessment summary of Abilify Maintena for schizophrenia
Figure 16: The author's drug assessment summary of Abilify Maintena for schizophrenia
Figure 17: Abilify Maintena sales for schizophrenia across the US, Japan, and five major EU markets, by country, 2017–26

LIST OF TABLES

Table 1: Abilify drug profile
Table 2: Approval history of Abilify for depression in the US and Japan
Table 3: Late-phase trials of Abilify for depression
Table 4: Abilify for depression – SWOT analysis
Table 5: Abilify bipolar disorder indication approvals
Table 6: Abilify drug profile
Table 7: Overview of key clinical trial data for Abilify in bipolar disorder
Table 8: Commonly observed adverse reactions in clinical trials of Abilify in bipolar mania
Table 9: Abilify drug profile
Table 10: Abilify pivotal trial data in schizophrenia
Table 11: Abilify sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017–26
Table 12: Abilify Maintena bipolar disorder indication approvals
Table 13: Abilify Maintena drug profile
Table 14: Overview of key clinical trial data for Abilify Maintena in bipolar disorder
Table 15: Commonly observed adverse reactions in clinical trials of Abilify Maintena in bipolar I disorder
Table 16: Abilify Maintena drug profile
Table 17: Abilify Maintena pivotal trial data in schizophrenia
Table 18: Abilify Maintena other late-phase clinical data in schizophrenia
Table 19: Abilify Maintena sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017–26

Table of Contents

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