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非アルコール性脂肪性肝炎 (NASH):KOL (キーオピニオンリーダー) による考察 (2017年)

Nonalcoholic Steatohepatitis (NASH): KOL Insight [2017]

発行 FirstWord 商品コード 520356
出版日 ページ情報 英文
納期: 即日から翌営業日
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非アルコール性脂肪性肝炎 (NASH):KOL (キーオピニオンリーダー) による考察 (2017年) Nonalcoholic Steatohepatitis (NASH): KOL Insight [2017]
出版日: 2017年06月01日 ページ情報: 英文

当レポートでは、非アルコール性脂肪性肝炎 (NASH)の主な上市済み薬剤および開発段階の薬剤を取り上げ、北米および欧州の12名のキーオピニオンリーダー (KOL) による各種見解をまとめています。


  • オベチコール酸は原発性胆汁性肝硬変 (PBC) 向けに承認されるが、NASHにおけるその展望は?
  • Cenicriviroc および selonsertib は第2相開発段階へ入るがKOLの予想は?
  • elafibranor はNASHにおいて幅広く用いられる可能性があるか?
  • Emricasan および Aramchol はNASHの異なるステージをターゲットとしているが、どの戦略が最も魅力的か?
  • 作用機序 (MOA) のどの初期段階が最も有望か?
  • NASHにおける医薬品承認を保証する鍵となるのはどの臨床エンドポイントか?
  • 臨床試験への登録と今後の課題の設計?
  • 非侵襲バイオマーカーはNASHにおける重要なアンメットニーズ?
  • 併用法はNASH治療の成功のカギ?
  • コスト・医療費償還はNASHの影響を抑制しているか?


  • 上市済み薬剤 (オフラベル)
    • pioglitazone (Actos/Glustin; Takeda/Eli Lilly)
    • ビタミンE
  • パイプライン薬
    • オベチコール酸 (Ocaliva; Intercept Pharmaceuticals)
    • elafibranor (Genfit Pharmaceuticals)
    • cenicriviroc (Allergan/Tobira Therapeutics)
    • selonsertib (Gilead)
    • emricasan (Novartis/Conatus Pharmaceuticals)
    • Aramchol (Galmed Pharmaceuticals)
    • semaglutide (Novo Nordisk)
    • GR-MD-02 (Galectin Therapeutics)
    • その他


  • 北米のKOL
  • 欧州のKOL

Will novel therapies revolutionise the treatment of NASH?

No drug therapies have been approved for patients with nonalcoholic steatohepatitis (NASH) but how is this set to change within the next five years? Allergan/Tobira's cenicriviroc and Gilead's selonsertib have entered the Phase III pipeline but how do they compare with other agents, Intercept's obeticholic acid and Genfit's elafibranor. How important are improvements in fibrosis and what do key opinion leaders (KOLs) believe will impact drug approval prospects? Experts discuss current study designs and endpoints and the challenges facing novel therapies such as long-term safety, cost and diagnosis.

Learn how KOLs see the market evolving, and how they expect developers to differentiate their pipeline therapies in KOL Insight: Nonalcoholic steatohepatitis (NASH). 6 US and 6 European KOLs give their insight on two off-label marketed products and 12 pipeline programmes. KOLs also provide their candid views on the potential for novel mechanisms of action.

Plus: Order the report and you'll receive three quarterly FirstWord Therapy Trends Update Bulletins!

Take a tour of the report now:

  • The table of contents
  • The key business questions answered
  • The key KOL quotes
  • See the therapies covered
  • Find out who the 6 EU & 6 US KOLs are
  • Review an extract from the report - 1 drug profile

Top Takeaways

  • Obeticholic acid approved for primary biliary cirrhosis (PBC) but what are its prospects in NASH? Find out how KOLs view the modifications of the pivotal Phase III REGENERATE study and whether they are concerned about long-term safety and cost?
  • Cenicriviroc and selonsertib have entered Phase III development but what are KOL expectations? Both drugs have demonstrated improvements in fibrosis in Phase II studies but what do the experts think about potential future outcomes?
  • Does elafibranor have potential for broad use in NASH? The Phase III RESOLVE-IT Phase III study is ongoing with Genfit's elafibranor but how do KOLs view the study design?
  • Emricasan and Aramchol are targeting different stages of NASH but which strategies are most appealing? Find out KOL opinions on different approaches targeting the multifaceted disease.
  • Which early-stage mechanisms of action (MOAs) show the most promise? Pipeline drugs with diverse mechanisms are in Phase II. Given the complexities of NASH pathogenesis, which MOAs are the most appealing to KOLs?
  • Which clinical endpoints are key to securing drug approval in NASH? Are improvements in fibrosis crucial or are KOLs satisfied with other endpoints such as resolution of NASH, NAFLD activity score (NAS) and hepatic venous pressure gradient (HVPG)?
  • Clinical trial enrolment and design an issue going forward? Companies have announced reductions in patient enrolment numbers in NASH clinical trials due to challenges encountered. Do KOLs have concerns about trial enrolment?
  • Non-invasive biomarkers a critical unmet need in NASH? Liver biopsy remains the gold standard for NASH diagnosis. Are KOLs concerned about the requirement of liver biopsies to monitor drug response and disease progression in clinical trials?
  • Are combination approaches the key to successfully treating NASH? Given the multitude of pathways involved in the pathogenesis of NASH, do KOLs agree that future treatment is most likely going to involve combination therapy?
  • Will cost and reimbursement restraints impact NASH? Cost-effectiveness of novel agents approved in NASH is likely to become an important consideration. Explore the concerns voiced by KOLs about the potential restrictions facing novel therapies.


“Combinations ensure [that] you're not just targeting one pathway. Fibrosis is important but so are the inflammatory cascade, insulin resistance and metabolic syndrome. I think that the most promising will be combinations of a primarily antifibrotic agent with an agent that specifically targets the metabolic pathway and insulin resistance.” US Key Opinion Leader.

“This is very developing field, a lot of labs around the world are looking for the ideal non-invasive biomarker for NASH, and I am quite confident that in the next five years we will discover the best one.” EU Key Opinion Leader.

Sample of therapies covered

Marketed Therapies (off-label)

  • pioglitazone (Actos/Glustin; Takeda/Eli Lilly)
  • vitamin E

Pipeline Therapies

  • obeticholic acid (Ocaliva; Intercept Pharmaceuticals)
  • elafibranor (Genfit Pharmaceuticals)
  • cenicriviroc (Allergan/Tobira Therapeutics)
  • selonsertib (Gilead)
  • emricasan (Novartis/Conatus Pharmaceuticals)
  • Aramchol (Galmed Pharmaceuticals)
  • semaglutide (Novo Nordisk)
  • GR-MD-02 (Galectin Therapeutics)
  • Plus 4 more

Sample of KOLs interviewed

KOLs from North America

  • Professor Scott L. Friedman, MD, Dean for Therapeutic Discovery and Chief of Division of Liver Diseases, The Icahn School of Medicine, Mount Sinai Hospital, New York City
  • Professor Joel E. Lavine, MD, PhD, Chief of the Division of Pediatric Gastroenterology, Hepatology and Nutrition, Morgan Stanley Children's Hospital and Columbia University Medical Center New York
  • Dr. Naim Alkhouri, MD, Staff Physician, Digestive Disease Institute and Cleveland Clinic's Children Hospital, Cleveland, Ohio

KOLs from Europe

  • Professor Vlad Ratziu, MD, PhD, Professor of Hepatology, Université Pierre et Marie Curie and the Hôpital Pitié-Salpêtrière Medical School, Paris, France
  • Professor Dr. Stefano Bellentani, MD, PhD, Gastroenterologist at Azienda USL di Modena, Italy
  • Professor Phillip Newsome, MD, Professor of Experimental Hepatology, Director of the Centre for Liver Research and Clinical Director of the Birmingham University Stem Cell Centre, UK
  • Plus 6 more

Ongoing Benefits

The world of pharma is ever changing and executives must always be up-to-date with new developments that could affect their own products, position and research. That is why FirstWord's guarantee to keep Therapy Trends clients up to date with Update Bulletins offers a real commercial advantage.

Update Bulletins include expert insight and analysis based on FirstWord analyst re-engagement with the KOLs after major events such as product approvals, key data releases and major conferences to deliver the most valuable insights with each update.

  • Your Therapy Trends Report purchase entitles you to receive three Update Bulletins, which are published approximately every three months for 12 months following the report's publication date.
  • You will receive a copy of each Update Bulletin once available, which are issued each quarter after the publication date.
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