Seroquel/Seroquel XR
Author: Stephanie Yip
Publisher: Datamonitor Healthcare
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Drug Overview
The Seroquel franchise contains quetiapine, which acts as an antagonist at multiple neurotransmitter receptors in the brain, such as serotonin 5-HT1A and 5-HT2, dopamine D1 and D2, histamine H1, and adrenergic alpha 1 and alpha 2 receptors.
AstraZeneca initially launched Seroquel in the US and Europe in 1997 for the treatment of schizophrenia. In October 2003, the company successfully extended Seroquel’s use as both a monotherapy and adjunct therapy to lithium or valproate for the treatment of acute manic episodes associated with bipolar I disorder. The company subsequently sought several indication expansions for Seroquel within bipolar disorder, and launched a sustained-release version – Seroquel XR – which allows a more convenient once-daily dosing regimen.
In December 2010, Astellas Pharma was granted the exclusive rights to Seroquel XR in Japan. In July 2017, exclusive marketing rights were transferred to Kyowa Pharmaceutical upon the drug’s approval for bipolar depression. AstraZeneca’s commercial partner for the Seroquel franchise in Japan, Astellas, had also been developing Seroquel XR for major depressive disorder (MDD), but has not progressed it beyond Phase II after a negative trial. The immediate-release Seroquel formulation is not approved for MDD in any market.
CONTENTS
5 OVERVIEW
5 Drug Overview
6 Product Profiles
6 Seroquel XR : Depression
16 Seroquel/Seroquel XR : Bipolar disorder
36 Seroquel/Seroquel XR : Schizophrenia
LIST OF FIGURES
11 Figure 1: Datamonitor Healthcare’s drug assessment summary of Seroquel XR for depression
12 Figure 2: Datamonitor Healthcare’s drug assessment summary of Seroquel XR for depression
14 Figure 3: Seroquel XR sales for depression across the US, Japan, and five major EU markets, by country, 2017–26
30 Figure 4: Seroquel/Seroquel XR for bipolar disorder – SWOT analysis
31 Figure 5: Datamonitor Healthcare’s drug assessment summary for Seroquel/Seroquel XR in bipolar disorder
32 Figure 6: Datamonitor Healthcare’s drug assessment summary for Seroquel/Seroquel XR in bipolar disorder
41 Figure 7: Seroquel/Seroquel XR for schizophrenia – SWOT analysis
42 Figure 8: Datamonitor Healthcare’s drug assessment summary of Seroquel/Seroquel XR for schizophrenia
43 Figure 9: Datamonitor Healthcare’s drug assessment summary of Seroquel/Seroquel XR for schizophrenia
45 Figure 10: Seroquel/Seroquel XR sales for schizophrenia across the US, Japan, and five major EU markets, by country,2017–26
LIST OF TABLES
7 Table 1: Seroquel XR drug profile
7 Table 2: Approval history of Seroquel XR for depression in the US and five major EU markets
9 Table 3: Late-phase trials of Seroquel XR for depression
10 Table 4: Seroquel XR for depression – SWOT analysis
17 Table 5: Seroquel/Seroquel XR bipolar disorder indication approvals
18 Table 6: Seroquel/Seroquel XR drug profile
20 Table 7: Overview of key pivotal trial data for Seroquel in adult bipolar disorder patients
24 Table 8: Adverse reactions in ≥5% of Seroquel-treated adult patients in Phase III trials for bipolar disorder
26 Table 9: Overview of key pivotal trial data for Seroquel in pediatric bipolar disorder patients
28 Table 10: Overview of key pivotal trial data for Seroquel XR in adult bipolar disorder
29 Table 11: Key side effects (≥5%) reported in clinical trials of Seroquel XR in bipolar disorder
36 Table 12: Seroquel/Seroquel XR drug profile
37 Table 13: Seroquel/Seroquel XR pivotal trial data in schizophrenia
46 Table 14: Seroquel/Seroquel XR sales for schizophrenia across the US, Japan, and five major EU markets, by country ($m), 2017–26
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