Latuda
Publisher: Datamonitor Healthcare
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Drug Overview
Latuda (lurasidone; Sumitomo Dainippon/Angelini) contains the atypical antipsychotic lurasidone, which acts as an antagonist of dopamine receptors D2, and serotonin receptors 5-HT2A. By inhibiting the synaptic reuptake of dopamine and serotonin, Latuda helps to normalize brain activity and reduce schizophrenia symptoms.
In 2011, Sumitomo Dainippon and Takeda entered into an agreement for the joint development and commercialization of Latuda in the EU (except for in the UK, where Sumitomo Dainippon retained exclusive rights), for the treatment of schizophrenia and bipolar disorder. Takeda terminated this alliance in May 2015, with all rights transferring back to Sumitomo Dainippon’s subsidiary Sunovion Pharmaceuticals. In November 2017, Sumitomo Dainippon announced a partnership with Angelini for the marketing and commercialization of Latuda in 29 European countries. While Sumitomo Dainippon will continue to supply Latuda in some EU countries including the UK, Angelini is now responsible for Latuda’s expansion to other countries. Latuda’s launch in Italy at the end of 2017 marked the first fruits of this strategic partnership.
Latuda has not yet been approved in Japan, but is in Phase III development for bipolar depression and schizophrenia. Sumitomo Dainippon plans to apply for manufacturing and marketing approval of Latuda in Japan in 2019. In the EU, Latuda is only approved for the treatment of schizophrenia.
CONTENTS
4 OVERVIEW
4 Drug Overview
5 Product Profiles
5 Latuda : Depression
11 Latuda : Bipolar disorder
27 Latuda : Schizophrenia
LIST OF FIGURES
22 Figure 1: Latuda for bipolar disorder – SWOT analysis
23 Figure 2: Datamonitor Healthcare’s drug assessment summary for Latuda in bipolar disorder
24 Figure 3: Datamonitor Healthcare’s drug assessment summary for Latuda in bipolar disorder
32 Figure 4: Latuda for schizophrenia – SWOT analysis
33 Figure 5: Datamonitor Healthcare’s drug assessment summary of Latuda for schizophrenia
34 Figure 6: Datamonitor Healthcare’s drug assessment summary of Latuda for schizophrenia
36 Figure 7: Latuda sales for schizophrenia across the US, Japan, Germany, Italy, Spain, and the UK, by country, 2017–26
LIST OF TABLES
6 Table 1: Latuda drug profile
8 Table 2: Latuda Phase III data in depression
9 Table 3: Latuda for depression – SWOT analysis
12 Table 4: Latuda bipolar disorder indication approvals
13 Table 5: Latuda drug profile
15 Table 6: Overview of pivotal Phase III PREVAIL trials of Latuda in adults with bipolar depression
16 Table 7: Adverse reactions in ≥5% of Latuda-treated adult patients in bipolar depression studies
17 Table 8: Overview of the Phase III ILLUMINATE trial of Latuda in adolescents and children with bipolar depression
18 Table 9: Adverse reactions in ≥5% of Latuda-treated pediatric patients in bipolar depression studies
19 Table 10: Overview of key Japanese clinical trial data for Latuda in bipolar disorder
21 Table 11: Overview of clinical trial data for Latuda in maintenance treatment of bipolar I disorder
27 Table 12: Latuda drug profile
29 Table 13: Latuda pivotal trial data in schizophrenia
32 Table 14: Latuda other late-phase trial data in schizophrenia
37 Table 15: Latuda sales for schizophrenia across the US, Japan, Germany, Italy, Spain, and the UK, by country ($m), 2017–26
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