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疾患分析:慢性腎臓病における貧血

Disease Analysis: Anemia in Chronic Kidney Disease

発行 Datamonitor Healthcare 商品コード 939973
出版日 ページ情報 英文 84 Pages
納期: 即日から翌営業日
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本日の銀行送金レート: 1USD=107.71円で換算しております。
疾患分析:慢性腎臓病における貧血 Disease Analysis: Anemia in Chronic Kidney Disease
出版日: 2020年04月21日 ページ情報: 英文 84 Pages
概要

慢性腎疾患(CKD)市場における貧血は、高いヘモグロビン値 (Hb値) を目標とする際の心血管イベントのリスクが増加したことから、Hbの目標値が下がり、薬剤の投与を決定する際の警戒感が高くなったため、特に米国において、ベストセラーかつ標準治療となっている赤血球生成刺激剤 (ESA製剤) の使用が減少し、苦戦しています。またバイオシミラーは、バイオシミラーの短時間作用型ESAが使用の大部分を占める欧州を中心に、打撃を与えています。米国で最初のバイオシミラーであるRetacritは、2018年に承認されたため、現在も増加しています。ロキサダスタットは、既に日本と中国では承認されていますが、2020年後半に重要な米国市場での最初の承認に向けかって進んでおり、ESAは経口および潜在的に安全なHIF-PH阻害剤によって最終的に置き換えられる可能性があり、さらに相当なシェアを失う可能性があります。しかし、FDAのレビューから詳細を確認することが重要です。 HIF-PH阻害剤は、透析患者に必要なIV鉄の投与量を減らし、その他の利点もあるようです。

当レポートでは、慢性腎臓病における貧血向け治療薬市場について調査分析し、疾患の背景、主な治療ガイドライン、市販薬・パイプライン薬、臨床試験の情勢、予測、アンメットニーズなどについて分析しています。

概要

  • 最新の要点

疾患の背景

  • 定義
  • 患者のセグメンテーション

治療

  • 主な治療ガイドライン
  • KDIGOガイドライン
  • JSDTガイドライン

疫学

  • 有病率の調査手法

市販薬

パイプライン薬

主な規制イベント

  • 日本、バイオシミラーのテリパラチドとダルベポエチンを承認

成功の確率

臨床試験の情勢

  • スポンサー:ステータス別
  • スポンサー:フェーズ別
  • 最新のイベント

薬物評価モデル

  • 赤血球生成刺激剤 (ESA製剤)
  • 鉄製品
  • HIF-PH阻害剤

市場力学

今後のトレンド

コンセンサス予測

最新イベントとアナリストの見解

  • 慢性腎不全、透析依存性および非依存性貧血向けロキサダスタット(2019年5月9日)
  • 慢性腎不全、透析依存性および非依存性貧血向けバダデュスタット(2019年3月12日)
  • 慢性腎不全、透析依存性および非依存性貧血向けロキサダスタット(2018年12月20日)

主な今後のイベント

アンメットニーズ

  • CKDにおける貧血のアンメットニーズのランキング

参考文献

  • 処方薬情報

付録

図表

LIST OF FIGURES

  • Figure 1: WHO definition of anemia and segmentation by severity
  • Figure 2: Japan - JSDT definition of anemia
  • Figure 3: Rates of the stages of anemia among adult CKD patients seen by nephrologists
  • Figure 4: CV outcomes in US prescribing information of ESAs
  • Figure 5: US dialysis patients: change in ESA usage and dosing, as well as Hb levels
  • Figure 6: KDIGO guidelines
  • Figure 7: JSDT guidelines
  • Figure 8: JSDT guidelines [continued]
  • Figure 9: JSDT guidelines [continued]
  • Figure 10: Trends in prevalent cases of anemia in CKD, 2018-27
  • Figure 11: Overview of pipeline drugs for anemia in CKD in the US
  • Figure 12: Pipeline drugs for anemia in CKD, by company
  • Figure 13: Pipeline drugs for anemia in CKD, by drug type
  • Figure 14: Pipeline drugs for anemia in CKD, by classification
  • Figure 15: Probability of success in the anemia in CKD, dialysis-dependent pipeline
  • Figure 16: Probability of success in the anemia in CKD, dialysis-independent pipeline
  • Figure 17: Clinical trials in anemia
  • Figure 18: Top 10 drugs for clinical trials in anemia
  • Figure 19: Top 10 companies for clinical trials in anemia
  • Figure 20: Trial locations in anemia
  • Figure 21: Anemia trials status
  • Figure 22: Anemia trials sponsors, by phase
  • Figure 23: Datamonitor Healthcare's drug assessment summary for anemia in CKD
  • Figure 24: Market dynamics in anemia in CKD: erythropoiesis-stimulating agents
  • Figure 25: Market dynamics in anemia in CKD: iron products
  • Figure 26: Market dynamics in anemia in CKD: HIF-PH inhibitors
  • Figure 27: Future trends in anemia in CKD
  • Figure 28: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (May 9, 2019)
  • Figure 29: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (March 12, 2019)
  • Figure 30: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (December 20, 2018)
  • Figure 31: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (December 20, 2018)
  • Figure 32: Key upcoming events in anemia in CKD, dialysis-dependent
  • Figure 33: Key upcoming events in anemia in CKD, dialysis-independent
  • Figure 34: Average scores of unmet needs in the US (n=20)
  • Figure 35: Average scores of unmet needs in Europe (n=21)

LIST OF TABLES

  • Table 1: US non-dialysis CKD patients: percentage on ESAs
  • Table 2: Prevalent cases of anemia in CKD, 2018-27
  • Table 3: Marketed drugs for anemia in CKD, dialysis-dependent
  • Table 4: Marketed drugs for anemia in CKD, dialysis-independent
  • Table 5: Pipeline drugs for anemia in CKD, dialysis-dependent, in the US
  • Table 6: Pipeline drugs for anemia in CKD, dialysis-independent, in the US
  • Table 7: Historical global sales, by drug ($m), 2015-18
  • Table 8: Forecasted global sales, by drug ($m), 2020-24
  • Table 9: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (May 9, 2019)
  • Table 10: Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (March 12, 2019)
  • Table 11: Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (December 20, 2018)
目次
Product Code: DMKC0214699

Latest key takeaways

The anemia in chronic kidney disease (CKD) market has struggled as usage of high-selling, standard-of-care, injectable erythropoiesis-stimulating agents (ESAs) has declined, especially in the US, due to an increased risk of cardiovascular events when targeting higher Hb levels, which has led to lower Hb targets and more caution when deciding to initiate the drugs. Biosimilars have also taken their toll, particularly in Europe, where biosimilar short-acting ESAs have taken a majority share of usage. The first biosimilar in the US, Retacrit, was only approved in 2018, so is still ramping. The ESAs are poised to lose substantial further share and possibly be eventually displaced by the oral and potentially safer HIF-PH inhibitors, with roxadustat on track for initial approval in the important US market in late 2020, having already been approved in Japan and China. It will be important to see, though, more details from its FDA review. The HIF-PH inhibitors also reduce the dose of IV iron needed in dialysis patients, and appear to have other advantages as well.

ESAs

Despite dose reductions, ESAs are still currently the mainstay of anemia treatment in dialysis, used in at least 80% of patients in major markets, but in non-dialysis CKD anemia, ESAs are less commonly used, due to the need for injection, safety issues, broader spectrum of anemia severity, and cost. The first-on-the-market shorter-acting intravenous ESAs are more suited for dialysis than other settings, given with three-times weekly (TIW) dosing. Longer-acting products can be given intravenously or, as more convenient for non-dialysis patients, subcutaneously. In dialysis, the decision on which ESAs to use can vary greatly by country, impacted by cost, contractual arrangements (eg with dialysis providers Fresenius and DaVita in the US, which control a majority of the market), preferences for dosing frequencies, and practical issues at dialysis centers.

In the US, the first ESA to be approved, Amgen's short-acting Epogen, is still the largest-selling branded product, as it has retained substantial share in the dialysis market. Outside the US, Amgen's longer-acting Aranesp leads, though a portion of its sales are in oncology indications. Biosimilars to Aranesp have been approved in Japan, where it was favored over shorter-acting agents. Mircera, which is even longer acting, has continued to grow, especially in the US, where its launch was delayed until 2015, with sales driven by Vifor's arrangement with Fresenius and expansion to mid-sized and independent dialysis clinics, though overall ESA sales have continued to decline.

IV irons

Iron is the other major anemia treatment, used for patients with iron deficiency from a potential multitude of causes associated with CKD. IV irons are particularly important in the dialysis segment, as ESAs increase iron requirements for red blood cell production and IV iron can readily be given in conjunction with dialysis. In non-dialysis patients, oral iron is more convenient, though many patients have gastrointestinal side-effects that can impact compliance.

Non-dextran IV irons are thought to have a lower rate of severe acute adverse events, and Vifor's Venofer, sold by Daiichi in the US, took the lead early on. Venofer has since lost share in the overall IV iron segment to newer options that allowed higher dosing with fewer administrations, especially Vifor's own Injectafer, which now leads the overall IV iron segment in sales, though the growth of these has mainly been in non-dialysis patients and non-CKD indications, where the dosing advantage is more important and outweighs Injectafer's higher price - it is also not specifically labeled for dialysis patients in the US. As a result, Venofer still leads in nephrology sales, due to its use in the US dialysis market. Outside the US, including Europe, iron sucrose similars have surpassed Venofer in gross sales, despite efforts to show they do not have the same efficacy and safety, but sales for both are modest. Outcomes studies of Injectafer and Pharmacosmos's Monoferric in the related comorbidity of heart failure are expected in 2021, and if positive, could expand usage in CKD patients with heart failure. Monoferric can be given in a single dose and was just approved in the US in 2020, with a non-dialysis indication, though sales in Europe have been moderate and a patent infringement lawsuit seeking to keep it off the market was filed in February

2020. HIF-PH inhibitors

The HIF-PH inhibitors have the advantages of oral administration, potentially improved safety (as they more physiologically impact erythropoietin than ESAs), improved iron utilization, and possibly efficacy in certain patients that can be more difficult to treat with ESAs. Hence, they could take substantial share and possibly eventually displace the ESAs, as well as grow anemia treatment in non-dialysis CKD. They are likely to also reduce IV iron use in dialysis patients. More details from the pivotal programs are needed first, though. Roxadustat appears to be at least as effective as ESAs, and the others have some evidence suggesting that as well, especially since efficacy can be a matter of dose titration, though data from the global Phase III studies of these other candidates are pending for later this year.

Only roxadustat has CV safety data so far, and while there are signs of a potential CV advantage, the picture may not be as clear as one might have hoped for, though that may just be an indication that ESAs are not as dangerous at the lower Hb targets used. In dialysis patients, there was a benefit on MACE+ versus epoetin alfa, the European endpoint, which is encouraging. Part of the benefit, though, was due to heart failure, rather than more typical atherosclerotic endpoints, and more data are needed to see if that was related to lower hypertension, as well as whether there were any differences in various thrombotic events. There was a substantial reduction in events in the incident dialysis subgroup, but details have not been released on the chronic dialysis subgroup. Some controversies over the data have been raised, but more details will likely come out at an FDA advisory committee meeting. In non-dialysis patients, it was positive that roxadustat demonstrated non-inferiority to placebo on CV outcomes. Rates of MACE and MACE+ were slightly numerically higher than placebo, with a somewhat larger numerical increase in the individual endpoint of stroke, though these could all be due to chance. It was somewhat curious, though, that the pattern of slightly higher MACE and a more pronounced increase in stroke was similar to what was seen in Aranesp's large TREAT study, which contributed to concern over ESAs, though the increase in stroke with Aranesp was substantially higher and statistically significant.

Roxadustat is also being dosed TIW, which may be more difficult for non-dialysis patients to remember, opening the door to competitors vadadustat and daprodustat, which have daily dosing, though there may be ways around the issue. Global Phase III details for vadadustat and daprodustat are expected this year, which will help to better define their product profiles, as well as how the class is viewed compared to ESAs, particularly in terms of CV side-effects. However, the major non-dialysis studies for vadadustat and daprodustat with CV outcomes have ESA comparators rather than placebo, and if there is not much difference, they will not have the comparison against placebo in their favor. Nevertheless, their hope is that demonstrating benefits on other secondary outcomes will contribute to a commercial advantage, even if the drugs are shown to be no worse on CV outcomes than ESAs.

At least the initial HIF-PH inhibitors should receive an extra payment for two years under Medicare's TDAPA, though it is not clear if MedPAC recommendations may impact that.

General likelihood of approval in the indications

The overall likelihood of approval for Phase I assets is 23% for anemia in dialysis-dependent CKD and 38.1% for anemia in dialysis-independent CKD, with the average probabilities that a drug advances from Phase III at 87.5% and 85.7%, respectively. It takes on average 9.7-9.8 years for drugs in these indications to move from Phase I to approval, compared to 9.1 years in the overall hematology space.

TABLE OF CONTENTS

OVERVIEW

  • Latest key takeaways

DISEASE BACKGROUND

  • Definition
  • Patient segmentation

TREATMENT

  • Major treatment guidelines
  • KDIGO guidelines
  • JSDT guidelines

EPIDEMIOLOGY

  • Prevalence methodology

MARKETED DRUGS

PIPELINE DRUGS

KEY REGULATORY EVENTS

  • Japan Approves Biosimilar Teriparatide And Darbepoetin

PROBABILITY OF SUCCESS

CLINICAL TRIAL LANDSCAPE

  • Sponsors by status
  • Sponsors by phase
  • Recent events

DRUG ASSESSMENT MODEL

  • Erythropoiesis-stimulating agents
  • Iron products
  • HIF-PH inhibitors

MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION

  • Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (May 9, 2019)
  • Vadadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (March 12, 2019)
  • Roxadustat for Anemia Due to Chronic Renal Failure, Dialysis-Dependent and -Independent (December 20, 2018)

KEY UPCOMING EVENTS

UNMET NEEDS

  • Rankings of unmet needs in anemia in CKD

BIBLIOGRAPHY

  • Prescription information

APPENDIX