한글목차

포스타마티닙 이나트륨(TAVALISSE, R-985788)은 Rigel pharmaceuticals가 개발한 경구용 생물학적 제제로 지속성/만성 성인 특발성 혈소판감소성 자반증 치료제로 승인되었습니다. 이 치료제는 FcR에 의해 촉발되는 Syk 의존적 식균작용시 세포 골격의 재배열을 억제합니다. 리겔에 따르면 포스타티닙은 SYK 키나아제를 통해 대식세포와 B세포 모두에서 IgG 수용체 신호전달을 억제하는 독특한 작용기전을 가지고 있습니다.

TAVALISSE는 미국과 EU에서 만성 ITP 치료제로 승인되었습니다. 일본에서는 제조판매 승인 신청 중입니다.

1회 100mg을 1일 2회 경구 투여하고, 1개월 후 혈소판 수가 50×109/L 이상으로 증가하지 않으면 150mg을 1일 2회로 증량합니다. 출혈 위험을 줄이기 위해 필요한 혈소판 수치 50×109/L 이상을 달성하고 유지하기 위해서는 최소 용량의 타발리스를 사용해야 하며, 타발리스는 식사와 관계없이 복용할 수 있습니다. 타발리스 TAVALISSE 복용을 잊어버린 경우, 환자는 다음 용량을 정시에 복용하도록 지시받아야 합니다.

포스타티닙은 비장 티로신 키나아제(SYK)에 대한 활성이 입증된 티로신 키나아제 억제제입니다. 포스타티닙의 주요 대사산물인 R406은 Fc 활성화 수용체 및 B세포 수용체의 신호전달을 억제합니다. 포스타티닙의 대사산물 R406은 항체를 통한 혈소판 파괴를 억제합니다.

주요 7개국의 TAVALISSE 시장에 대해 조사했으며, 시장의 개요와 2023-2032년 판매 예측 데이터, 경쟁 구도 및 국가별 동향 등을 제공하고 있습니다.

목차

제1장 리포트의 서론

제2장 면역성 혈소판 감소증(ITP)에 대한 TAVALISSE의 개요

• 제품 상세
• 임상 개발
  • 임상 연구
  • 임상시험 정보
  • 안전성과 유효성
• 규제상 마일스톤
• 기타 개발 활동
• 제품 개요

제3장 경쟁 구도(출시 치료법)

제4장 경쟁 구도(후기 단계 신규 치료법)

제5장 TAVALISSE 시장 평가

• ITP에 대한 TAVALISSE의 시장 전망
• 주요 7개국 시장 분석
  • 주요 7개국에서 ITP에 대한 TAVALISSE의 시장 규모
• 국가별 시장 분석
  • 미국
  • 독일
  • 영국

제6장 SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

“"TAVALISSE Drug Insight and Market Forecast - 2032" ” report provides comprehensive insights about TAVALISSE for immune thrombocytopenic purpura (ITP) in the seven major markets. A detailed picture of the TAVALISSE for ITP in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2019 -2032 is provided in this report along with a detailed description of the TAVALISSE for ITP. The report provides insights about mechanism of action, dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of future market assessments inclusive of the TAVALISSE market forecast analysis for ITP in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in ITP.

Drug Summary:

Fostamatinib disodium (also known as TAVALISSE; R-985788) is an orally-bioavailable investigational agent developed by Rigel pharmaceuticals and approved for treating patients suffering from persistent/chronic adult idiopathic thrombocytopenic purpura. The therapeutic candidate inhibits FcR-triggered, Syk-dependent cytoskeletal rearrangement during phagocytosis. As stated by Rigel Pharmaceuticals, fostamatinib has a unique mechanism of action, blocking IgG receptor signaling in both macrophages and B cells via SYK kinase.

TAVALISSE is approved in the US and the EU to treat chronic ITP. The company has submitted a new drug application for manufacturing and marketing approval in Japan.

Dosage

TAVALISSE is initiated at a dose of 100 mg taken orally twice daily. After a month, if the platelet count has not increased to at least 50 × 109/L, the dose should be increased to 150 mg twice daily. The lowest dose of TAVALISSE should be used to achieve and maintain a platelet count of at least 50 × 109/L as necessary to reduce the risk of bleeding. TAVALISSE may be taken with or without food. In the case of a missed dose of TAVALISSE, patients should be instructed to take their next dose at its regularly scheduled time.

Mechanism of action

Fostamatinib is a tyrosine kinase inhibitor with demonstrated activity against spleen tyrosine kinase (SYK). The major metabolite of fostamatinib, R406, inhibits signal transduction of Fc-activating receptors and B-cell receptors. The fostamatinib metabolite R406 reduces antibody-mediated destruction of platelets.

Scope of the Report:

The report provides insights into:

• A comprehensive product overview including the TAVALISSE description, mechanism of action, dosage and administration, research and development activities in immune thrombocytopenic purpura (ITP).
• Elaborated details on TAVALISSE regulatory milestones and other development activities have been provided in this report.
• The report also highlights the TAVALISSE research and development activities in ITP across the United States, Europe and Japan.
• The report also covers the patents information with expiry timeline around TAVALISSE.
• The report contains forecasted sales of TAVALISSE for ITP till 2032.
• Comprehensive coverage of the late-stage emerging therapies for ITP.
• The report also features the SWOT analysis with analyst views for TAVALISSE in ITP.

Methodology:

The report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

TAVALISSE Analytical Perspective by DelveInsight

In-depth TAVALISSE Market Assessment

This report provides a detailed market assessment of TAVALISSE for immune thrombocytopenic purpura (ITP) in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides forecasted sales data from 2023 to 2032.

TAVALISSE Clinical Assessment

The report provides the clinical trials information of TAVALISSE for ITP covering trial interventions, trial conditions, trial status, start and completion dates.

Report Highlights:

• In the coming years, the market scenario for immune thrombocytopenic purpura (ITP) is set to change due to the extensive research and incremental healthcare spending across the world; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence TAVALISSE dominance.
• Other emerging products for ITP are expected to give tough market competition to TAVALISSE and launch of late-stage emerging therapies in the near future will significantly impact the market.
• A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of TAVALISSE in ITP.
• Our in-depth analysis of the forecasted sales data of TAVALISSE from 2023 to 2032 will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the TAVALISSE in ITP.

Key Questions:

• What is the product type, route of administration and mechanism of action of TAVALISSE?
• What is the clinical trial status of the study related to TAVALISSE in immune thrombocytopenic purpura (ITP) and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the TAVALISSE development?
• What are the key designations that have been granted to TAVALISSE for ITP?
• What is the forecasted market scenario of TAVALISSE for ITP?
• What are the forecasted sales of TAVALISSE in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain, and the United Kingdom), and Japan?
• What are the other emerging products available and how are these giving competition to TAVALISSE for ITP?
• Which are the late-stage emerging therapies under development for the treatment of ITP?

Table of Contents

1. Report Introduction

2. TAVALISSE Overview in ITP

• 2.1. Product Detail
• 2.2. Clinical Development
  • 2.2.1. Clinical studies
  • 2.2.2. Clinical trials information
  • 2.2.3. Safety and efficacy
• 2.3. Regulatory Milestone
• 2.4. Other Developmental Activities
• 2.5. Product Profile

3. Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging Therapies)

5. TAVALISSE Market Assessment

• 5.1. Market Outlook of TAVALISSE in ITP
• 5.2. 7MM Analysis
  • 5.2.1. Market Size of TAVALISSE in the 7MM for ITP
• 5.3. Country-wise Market Analysis
  • 5.3.1. Market Size of TAVALISSE in the United States for ITP
  • 5.3.2. Market Size of TAVALISSE in Germany for ITP
  • 5.3.3. Market Size of TAVALISSE in France for ITP
  • 5.3.4. Market Size of TAVALISSE in Italy for ITP
  • 5.3.5. Market Size of TAVALISSE in Spain for ITP
  • 5.3.6. Market Size of TAVALISSE in the United Kingdom for ITP
  • 5.3.7. Market Size of TAVALISSE in Japan for ITP

6. SWOT Analysis

7. Analysts' Views

8. Appendix

• 8.1. Bibliography
• 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options