Disease Analysis: Chronic Heart Failure
Publisher: Datamonitor Healthcare
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Definition
Chronic heart failure (CHF) is a progressive condition in which the heart muscle is unable to pump enough blood to meet the needs of the body. CHF can result from functional abnormalities such as ventricular dysfunction or arrhythmias, or structural disorders of the myocardium or valves.
Latest key takeaways
- Chronic heart failure (CHF) is a progressive condition in which the heart muscle is unable to pump enough blood to meet the needs of the body, typically leading to symptoms such as dyspnea, exercise intolerance, and fluid retention. Datamonitor Healthcare estimates that in 2021, there were approximately 83.0 million CHF cases in Asia, Europe, Latin America and the Caribbean, Northern America, and Oceania combined.
- In many cases of CHF, compensatory mechanisms of the failing heart eventually lead to a worsening of the disease. These compensatory mechanisms include an increase in cardiac output, increased ventricular volume and wall thickness through ventricular remodeling, and increased blood pressure through the activation of the renin-angiotensin-aldosterone system (RAAS). These temporary measures help to mask the problems of heart failure in the short term, which may explain why many patients remain undiagnosed in the early stages of the disease. Despite early beneficial effects, these measures eventually lead to a vicious cycle of worsening heart failure. The majority of CHF treatments are based on an understanding and interruption of these compensatory mechanisms, which also means polypharmacy is often required to adequately manage patients. However, despite significant knowledge of these mechanisms, the five-year survival rate of CHF is less than 60%.
- CHF patients are divided into two main groups: those with reduced ejection fraction (HFrEF) and those with preserved ejection fraction (HFpEF), as defined by the measurement of left ventricular ejection fraction (LVEF), the central measure of left ventricular systolic function.
- The CHF market is expected to grow significantly over the next 10 years across the US, Japan, and five major European markets (France, Germany, Italy, Spain, and the UK). The CHF market has predominantly been saturated with generics, which has limited market revenue; however, there are a growing number of late-stage pipeline therapies, which, combined with the rising disease prevalence, will be major drivers of market growth.
- Sodium-glucose cotransporter-2 (SGLT-2) inhibitors are beginning to alter the existing CHF treatment landscape, as seen in updates made to treatment guidelines in the US, EU, and Japan, which now recommend the use of SGLT-2 inhibitors in the first line, in combination with drugs targeting RAAS, beta blockers, and mineralocorticoid receptor antagonists (MRAs).
- High prices of branded therapies will translate to high revenues despite the large number of generics on the market. The SGLT-2 inhibitors approved for CHF – Boehringer Ingelheim and Eli Lilly’s Jardiance and AstraZeneca’s Farxiga – will be major market growth drivers, as they are expected to experience strong uptake in both diabetic and non-diabetic patients. SGLT-2 inhibitors are expected to capture the greatest market share in diabetic patients due to the convenience and cost-saving benefit of using one medication for two indications.
- The CHF market is becoming an increasingly active space, with multiple candidates in advanced development for both HFrEF and HFpEF. Therapies in mid-to-late-stage development for CHF focus on a wide variety of targets, and include both oral and injectable drug candidates.
- The overall likelihood of approval of a Phase I heart failure asset is 7.3%, and the average probability a drug advances from Phase III is 51.3%. Heart failure drugs, on average, take 11.5 years from Phase I to approval, compared to 10.5 years in the overall cardiovascular space.
- Upcoming approvals for CHF expected in 2023 include omecamtiv mecarbil for use in HFrEF, and Zynquista for use in both HFrEF and HFpEF.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
10 DISEASE BACKGROUND
10 Definition
10 Diagnosis
11 Risk factors
11 Symptoms
12 Patient segmentation
15 TREATMENT
15 Angiotensin-converting enzyme inhibitors
15 Angiotensin receptor blockers
15 Beta blockers
15 Mineralocorticoid receptor antagonists
16 SGLT-2 inhibitors
16 Hyperpolarization-activated cyclic nucleotide-gated channel blockers
16 Angiotensin receptor-neprilysin inhibitors
17 Other drug classes
17 New “quadruple therapy” guidelines
19 EPIDEMIOLOGY
19 Prevalence methodology
22 MARKETED DRUGS
22 CHFrEF
27 CHFpEF
29 PIPELINE DRUGS
29 CHFrEF
35 CHFpEF
41 KEY REGULATORY EVENTS
41 Keeping Track: Furoscix, SPN-830 Show Difficulties Of Drug-Device Combinations
41 FDA Accepts NDA for Sotagliflozin
41 FDA Requests Further Information On Omecamtiv Mecarbil’s NDA
41 Jardiance Receives Symptomatic Chronic Heart Failure Approval In Europe
42 Lexicon Withdraws Sotagliflozin NDA
42 Jardiance Gets Heart Failure Nod, But How Long Will Its Reign Last?
42 Cytokinetics Joins HFrEF Pursuit
43 Lilly Submits sNDA For Jardiance In Patients With HFpEF
44 PROBABILITY OF SUCCESS
45 LICENSING AND ASSET ACQUISITION DEALS
45 Imara Sells Tovinontrine To Cardurion Pharmaceuticals
45 India’s Mankind Licenses Entresto From Novartis
45 AstraZeneca And BenevolentAI Expand Collaboration
45 Cytokinetics Licenses China Rights For Omecamtiv To Ji Xing
47 CLINICAL TRIAL LANDSCAPE
48 Sponsors by status
49 Sponsors by phase
50 Recent events
52 DRUG ASSESSMENT MODEL
52 Entresto
53 Corlanor
53 Farxiga and Jardiance
54 Verquvo
54 Omecamtiv mecarbil
55 Zynquista (sotagliflozin)
56 Invokana (canagliflozin)
56 Furoscix
56 Kerendia (finerenone)
57 Revascor (MPC-150-IM)
58 MARKET DYNAMICS
59 FUTURE TRENDS
59 The high value of the CHF market will be driven by increased use of branded therapies
59 New approvals for HFpEF patients will contribute to growth of the CHF market
60 Approval of generically available spironolactone in HFpEF could limit the growth potential of the HFpEF market
60 Entresto faces competition from SGLT-2 inhibitors
62 CONSENSUS FORECASTS
66 RECENT EVENTS AND ANALYST OPINION
66 Farxiga for Chronic HFpEF and Chronic HFrEF (August 27, 2022)
67 Farxiga for Chronic HFpEF (August 27, 2022)
68 Farxiga for Chronic HFpEF (May 5, 2022)
69 Omecamtiv Mecarbil (Oral) for Chronic HFrEF (February 15, 2022)
70 Firibastat for Chronic HFrEF (August 27, 2021)
71 Jardiance for Chronic HFpEF (August 27, 2021)
74 Jardiance for Chronic HFpEF (July 6, 2021)
76 Esbriet for Chronic HFpEF (May 17, 2021)
77 Omecamtiv Mecarbil (Oral) for Chronic HFrEF (May 17, 2021)
80 Zynquista for Chronic HFpEF and Chronic HFrEF (May 17, 2021)
83 Entresto for Chronic HFrEF (May 15, 2021)
86 KEY UPCOMING EVENTS
87 KEY OPINION LEADER INSIGHTS
87 Marketed drugs
87 Pipeline drugs
88 Unmet needs
89 UNMET NEEDS
89 Additional treatments for HFpEF patients
89 Therapies that improve cardiac contractility in patients with HFrEF
89 Other unmet needs
89 Cardiologist rankings of unmet needs in CHF
92 BIBLIOGRAPHY
95 APPENDIX
LIST OF FIGURES
18 Figure 1: Summary of treatment guidelines in CHF (HFrEF)
18 Figure 2: Summary of treatment guidelines in CHF (HFpEF)
21 Figure 3: Trends in prevalent cases of CHF, 2018–27
29 Figure 4: Overview of pipeline drugs for CHFrEF in the US
30 Figure 5: Pipeline drugs for CHFrEF, by company
30 Figure 6: Pipeline drugs for CHFrEF, by drug type
30 Figure 7: Pipeline drugs for CHFrEF, by classification
35 Figure 8: Overview of pipeline drugs for CHFpEF in the US
36 Figure 9: Pipeline drugs for CHFpEF, by company
36 Figure 10: Pipeline drugs for CHFpEF, by drug type
36 Figure 11: Pipeline drugs for CHFpEF, by classification
44 Figure 12: Probability of success in the heart failure pipeline
47 Figure 13: Clinical trials in CHF
47 Figure 14: Top 10 drugs for clinical trials in CHF
48 Figure 15: Top 10 companies for clinical trials in CHF
48 Figure 16: Trial locations in CHF
49 Figure 17: CHF trials status
50 Figure 18: CHF trials sponsors, by phase
52 Figure 19: Datamonitor Healthcare’s drug assessment summary for CHF
58 Figure 20: Market dynamics in CHF
59 Figure 21: Future trends in CHF
69 Figure 22: Farxiga for Chronic HFpEF (May 5, 2022): Phase III – DELIVER (HFpEF)
74 Figure 23: Jardiance for Chronic HFpEF (August 27, 2021): Phase III – EMPEROR-Preserved
76 Figure 24: Jardiance for Chronic HFpEF (July 6, 2021): Phase III – EMPEROR-Preserved
77 Figure 25: Esbriet for Chronic HFpEF (May 17, 2021): Phase II – PIROUETTE
80 Figure 26: Omecamtiv Mecarbil (Oral) for Chronic HFrEF (May 17, 2021): Phase III – GALACTIC-HF
83 Figure 27: Zynquista for Chronic HFpEF and Chronic HFrEF (May 17, 2021): Phase III – SCORED, Phase III – SOLOIST-WHF (Heart Failure)
85 Figure 28: Entresto for Chronic HFrEF (May 15, 2021): Phase III – PARADISE-MI (Post Acute MI)
86 Figure 29: Key upcoming events in CHF
90 Figure 30: Average scores of unmet needs in CHF in the US (n=40)
91 Figure 31: Average scores of unmet needs in CHF in Europe (n=41)
LIST OF TABLES
13 Table 1: Classification of heart failure by LVEF
14 Table 2: NYHA functional classification based on severity of symptoms and physical activity
20 Table 3: Prevalent cases of CHF, 2018–27
23 Table 4: Marketed drugs for CHFrEF
28 Table 5: Marketed drugs for CHFpEF
32 Table 6: Pipeline drugs for CHFrEF in the US
38 Table 7: Pipeline drugs for CHFpEF in the US
63 Table 8: Historical global sales, by drug ($m), 2017–21
64 Table 9: Forecasted global sales, by drug ($m), 2022–26
66 Table 10: Farxiga for Chronic HFpEF and Chronic HFrEF (August 27, 2022)
67 Table 11: Farxiga for Chronic HFpEF (August 27, 2022)
68 Table 12: Farxiga for Chronic HFpEF (May 5, 2022)
70 Table 13: Omecamtiv Mecarbil (Oral) for Chronic HFrEF (February 15, 2022)
71 Table 14: Firibastat for Chronic HFrEF (August 27, 2021)
72 Table 15: Jardiance for Chronic HFpEF (August 27, 2021)
75 Table 16: Jardiance for Chronic HFpEF (July 6, 2021)
76 Table 17: Esbriet for Chronic HFpEF (May 17, 2021)
78 Table 18: Omecamtiv Mecarbil (Oral) for Chronic HFrEF (May 17, 2021)
80 Table 19: Zynquista for Chronic HFpEF and Chronic HFrEF (May 17, 2021)
84 Table 20: Entresto for Chronic HFrEF (May 15, 2021)
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