Disease Analysis: Chronic Heart Failure
Author: Hannah Cohen
Publisher: Datamonitor Healthcare
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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. Datamonitor Healthcare estimates that in 2018, there were approximately 80.5 million cases in Asia, Europe, Latin America and the Caribbean, Northern America, and Oceania combined.
- Datamonitor Healthcare forecasts the number of prevalent cases of CHF to increase by 9.1% between 2018 and 2027. These trends are driven by population demographics, as prevalence proportions were held constant throughout the forecast period.
- 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 the market revenue. Angiotensin-converting enzyme inhibitors remain the current standard-of-care therapy, and are used in every line of treatment except when using Entresto. However, there are a growing number of late-stage pipeline therapies, which, combined with the rising disease prevalence, will be the major drivers of market growth.
- Despite initially encountering reimbursement challenges which led to a slower than expected uptake, Entresto reached blockbuster status in 2018 and maintained solid growth in 2020, reaching global revenues of $2,497m. Continued uptake of Entresto in the CHF market due to favorable recommendations in treatment guidelines and its proven ability to reduce mortality will be a key driver of market growth. Entresto’s recent label expansion in the US to include the broad CHF population, based on the PARAGON-HF trial in HFpEF patients, will also contribute to growth.
- High prices of branded therapies will translate into high revenues, despite the large number of generics on the market. The SGLT-2 inhibitors, Jardiance and 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.
- Generic entry of dapagliflozin, ivabradine, and sacubitril/valsartan will attenuate market growth towards the end of the forecast period.
- The CHF market is becoming an increasingly active space, with 10 drug candidates currently in Phase III. 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 CHF asset is 6.2%, and the average probability a drug advances from Phase III is 47.6%. CHF drugs, on average, take 10.2 years from Phase I to approval, compared to 10.1 years in the overall cardiovascular space.
- Numerous high-impact upcoming events for drugs in the CHF space are expected in 2021, including Phase III trial results for a number of different drug candidates, such as data from Jardiance’s Phase III EMPEROR-Preserved trial.
CONTENTS
8 OVERVIEW
8 Latest key takeaways
9 DISEASE BACKGROUND
9 Definition
9 Diagnosis
10 Risk factors
10 Symptoms
11 Patient segmentation
14 TREATMENT
14 Angiotensin-converting enzyme inhibitors
14 Angiotensin receptor blockers
14 Beta blockers
14 Aldosterone antagonists
15 Hyperpolarization-activated cyclic nucleotide-gated channel blockers
15 Angiotensin receptor-neprilysin inhibitors
15 Other drug classes
17 EPIDEMIOLOGY
17 Prevalence methodology
20 MARKETED DRUGS
24 PIPELINE DRUGS
32 KEY REGULATORY EVENTS
32 New Entresto Label Looks Past Preserved/Reserved Framework
32 Merck & Co. Pushes Back On Modest Projections For Verquvo
32 Carmat To Launch Total Artificial Heart In Early 2021
32 Spironolactone TOPCAT Regional Analysis Falls Short At US FDA AdComm, But Hospitalizations Drive Vote
33 Tale Of Two Adcomms: US FDA Handling Of Entresto Data May Have Helped Avoid Aducanumab’s Fate
33 Novartis’ Entresto Gains US FDA Panel Nod For New Heart Failure Claim
33 Spironolactone Starts Out On ‘Unusual But Not Unprecedented’ Regulatory Path, Thanks To US FDA Reviewers
33 Novartis’ Entresto Labeling Expansion Bid Heads To US FDA Panel
34 NDAs And More: Recent Submissions For FDA Approval
34 Latest EU Filings
34 NDA Resubmission for scPharmaceuticals’ Furoscix
35 AZ To Adopt Indication-Based Pricing For Farxiga In Heart Failure
35 Novartis Seeks Entresto HFpEF Indication With Readjudicated PARAGON-HF Data
36 PROBABILITY OF SUCCESS
37 LICENSING AND ASSET ACQUISITION DEALS
37 Amgen Hands Omecamtiv Back To Cytokinetics
38 CLINICAL TRIAL LANDSCAPE
39 Sponsors by status
40 Sponsors by phase
41 Recent events
43 DRUG ASSESSMENT MODEL
43 Entresto
44 Corlanor
44 Farxiga and Jardiance
45 Verquvo
45 Omecamtiv mecarbil
46 ARRY-797
46 Finerenone
47 MPC-150-IM
48 MARKET DYNAMICS
49 FUTURE TRENDS
49 The high value of the CHF market will be driven by increased use of branded therapies
49 New approvals for HFpEF patients will contribute to growth of the CHF market
50 Approval of generically available spironolactone in HFpEF could limit the growth potential of the HFpEF market
50 Entresto faces competition from SGLT-2 inhibitors
50 Generic competition will offset growth in the CHF market
52 CONSENSUS FORECASTS
56 RECENT EVENTS AND ANALYST OPINION
56 Zynquista for CHF and Cardiomyopathies (January 14, 2021)
57 Entresto for CHF and Cardiomyopathies (December 15, 2020)
58 MPC-150-IM for CHF and Cardiomyopathies (December 14, 2020)
60 Entresto for CHF and Cardiomyopathies (December 11, 2020)
61 Furoscix for CHF and Cardiomyopathies (December 3, 2020)
61 Zynquista for CHF and Cardiomyopathies (November 16, 2020)
65 Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (November 13, 2020)
67 Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (October 8, 2020)
69 Entresto for CHF and Cardiomyopathies (August 30, 2020)
70 Jardiance for CHF and Cardiomyopathies (August 29, 2020)
72 Jardiance for CHF and Cardiomyopathies (July 30, 2020)
74 Danicamtiv for CHF and Cardiomyopathies (June 22, 2020)
76 Jardiance for CHF and Cardiomyopathies (June 19, 2020)
78 Farxiga for CHF and Cardiomyopathies (June 15, 2020)
79 Verquvo for CHF and Cardiomyopathies (June 11, 2020)
81 Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
83 Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
85 Verquvo for CHF and Cardiomyopathies (March 28, 2020)
88 KEY UPCOMING EVENTS
89 KEY OPINION LEADER INSIGHTS
89 Marketed drugs
89 Pipeline drugs
90 Unmet needs
91 UNMET NEEDS
91 Additional treatments for HFpEF patients
91 Therapies that improve cardiac contractility in patients with HFrEF
91 Other unmet needs
91 Cardiologist rankings of unmet needs in CHF
94 BIBLIOGRAPHY
95 Prescription information
97 APPENDIX
LIST OF FIGURES
16 Figure 1: Summary of treatment guidelines in CHF
19 Figure 2: Trends in prevalent cases of CHF, 2018–27
24 Figure 3: Overview of pipeline drugs for CHF in the US
24 Figure 4: Pipeline drugs for CHF, by company
25 Figure 5: Pipeline drugs for CHF, by drug type
25 Figure 6: Pipeline drugs for CHF, by classification
36 Figure 7: Probability of success in the CHF pipeline
38 Figure 8: Clinical trials in CHF
38 Figure 9: Top 10 drugs for clinical trials in CHF
39 Figure 10: Top 10 companies for clinical trials in CHF
39 Figure 11: Trial locations in CHF
40 Figure 12: CHF trials status
41 Figure 13: CHF trials sponsors, by phase
43 Figure 14: Datamonitor Healthcare’s drug assessment summary for CHF
48 Figure 15: Market dynamics in CHF
49 Figure 16: Future trends in CHF
64 Figure 17: Zynquista for CHF and Cardiomyopathies (November 16, 2020): Phase III – SOLOIST-WHF (Heart Failure Study)
65 Figure 18: Zynquista for CHF and Cardiomyopathies (November 16, 2020): Phase III – SCORED
67 Figure 19: Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (November 13, 2020): Phase III – GALACTIC-HF
70 Figure 20: Entresto for CHF and Cardiomyopathies (August 30, 2020): Phase III – PARALLAX
72 Figure 21: Jardiance for CHF and Cardiomyopathies (August 29, 2020): Phase III – EMPEROR-Reduced
74 Figure 22: Jardiance for CHF and Cardiomyopathies (July 30, 2020): Phase III – EMPEROR-Reduced
76 Figure 23: Danicamtiv for CHF and Cardiomyopathies (June 22, 2020): Phase Ib/IIa – Symptomatic DCM
78 Figure 24: Jardiance for CHF and Cardiomyopathies (June 19, 2020): Phase III – EMPERIAL-Preserved, Phase III – EMPERIALReduced
79 Figure 25: Farxiga for CHF and Cardiomyopathies (June 15, 2020): Phase III – DAPA-HF
81 Figure 26: Verquvo for CHF and Cardiomyopathies (June 11, 2020): Phase II – VITALITY-HFpEF
83 Figure 27: Mavacamten for CHF and Cardiomyopathies (May 11, 2020): Phase III – EXPLORER-HCM
85 Figure 28: Mavacamten for CHF and Cardiomyopathies (March 30, 2020): Phase II – MAVERICK-HCM
87 Figure 29: Verquvo for CHF and Cardiomyopathies (March 28, 2020): Phase III – VICTORIA
88 Figure 30: Key upcoming events in CHF
92 Figure 31: Average scores of unmet needs in CHF in the US (n=40)
93 Figure 32: Average scores of unmet needs in CHF in Europe (n=41)
LIST OF TABLES
12 Table 1: Definition of HFrEF and HFpEF
13 Table 2: New York Heart Association functional classification based on severity of symptoms and physical activity
18 Table 3: Prevalent cases of CHF, 2018–27
21 Table 4: Marketed drugs for CHF
26 Table 5: Pipeline drugs for CHF in the US
53 Table 6: Historical global sales, by drug ($m), 2015–19
54 Table 7: Forecasted global sales, by drug ($m), 2021–25
56 Table 8: Zynquista for CHF and Cardiomyopathies (January 14, 2021)
57 Table 9: Entresto for CHF and Cardiomyopathies (December 15, 2020)
59 Table 10: MPC-150-IM for CHF and Cardiomyopathies (December 14, 2020)
60 Table 11: Entresto for CHF and Cardiomyopathies (December 11, 2020)
61 Table 12: Furoscix for CHF and Cardiomyopathies (December 3, 2020)
62 Table 13: Zynquista for CHF and Cardiomyopathies (November 16, 2020)
66 Table 14: Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (November 13, 2020)
68 Table 15: Omecamtiv Mecarbil (Oral) for CHF and Cardiomyopathies (October 8, 2020)
69 Table 16: Entresto for CHF and Cardiomyopathies (August 30, 2020)
71 Table 17: Jardiance for CHF and Cardiomyopathies (August 29, 2020)
73 Table 18: Jardiance for CHF and Cardiomyopathies (July 30, 2020)
74 Table 19: Danicamtiv for CHF and Cardiomyopathies (June 22, 2020)
77 Table 20: Jardiance for CHF and Cardiomyopathies (June 19, 2020)
78 Table 21: Farxiga for CHF and Cardiomyopathies (June 15, 2020)
80 Table 22: Verquvo for CHF and Cardiomyopathies (June 11, 2020)
82 Table 23: Mavacamten for CHF and Cardiomyopathies (May 11, 2020)
84 Table 24: Mavacamten for CHF and Cardiomyopathies (March 30, 2020)
86 Table 25: Verquvo for CHF and Cardiomyopathies (March 28, 2020)
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