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Disease Analysis: Dyslipidemia

  • ID: 4895486
  • Report
  • November 2019
  • Region: Global
  • 103 pages
  • Datamonitor Healthcare
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Key Takeaways
  • The author estimates that in 2018 there were approximately 1.5 billion prevalent cases of dyslipidemia in adults aged 20 years and older worldwide, and forecasts that number to increase to 1.7 billion prevalent cases by 2027.
  • The dyslipidemia market is well established and the branded segment has seen declining sales due to generics. However, the market is poised to resume steady growth due to the introduction of novel agents, improved access with price competition, and new cardiovascular outcomes data with label expansions.
  • In the hypercholesterolemia segment, the injectable PCSK9 inhibitors have struggled due to payer restrictions, but declining net pricing in the US is hoped to improve access and spur growth, though this will depend on the extent to which payers retain prior authorization. Price competition may increase with the introduction of siRNA inclisiran, but Novartis also plans to use inclisiran’s more convenient maintenance dosing of every six months to pursue administration in healthcare provider offices, with medical rather than pharmacy benefit coverage, including Medicare Part B, to improve access. Inclisiran’s cardiovascular outcomes trial (CVOT) is also designed to show a numerically stronger topline benefit.
  • Oral bempedoic acid will be limited by modest low-density lipoprotein cholesterol (LDL-C) lowering, particularly on top of statins, but good efficacy with its fixed-dose combination with ezetimibe in statin-intolerant patients will be an important addition to that high-need segment. In addition, its oral route could lead it to be preferred initially in patients failing statins +/- ezetimibe who are not too far from goal, depending on the risk of the patient and whether the particular physician feels that reaching certain LDL-C targets is acceptable rather than driving it as low as possible. Given the large number of hypercholesterolemia patients not meeting goal, either with or without statin intolerance, if bempedoic acid’s CVOT is positive, it should still be fairly successful despite its modest efficacy.
  • In the hypertriglyceridemia segment (including mixed dyslipidemia), positive CVOT data for the omega-3 fatty acid (FA) Vascepa, a formulation of EPA, has already started to drive substantial growth, but while the FDA is sure to grant it a label expansion for secondary prevention, it is unclear what type of primary prevention patients the FDA will include in the indication. The drug’s prospects also largely depend on whether Epanova, a mixture of DHA and EPA, likewise has a positive CVOT. Epanova is likely to lag behind Vascepa if results are numerically not as strong, though it could benefit from AstraZeneca’s stronger primary care presence. Depending on the details, Epanova’s CVOT could also give physicians more confidence in generics of DHA/EPA when used in a high enough dose, though sponsors of other branded formulations, like CaPre, are hoping that would lead some to prefer their own formulations for other features. Vascepa’s success could revive interest in triglycerides as a broader target, though its CV benefit may involve a number of other effects as well.
  • While fibrates have mixed CVOT data and failed to show a benefit in combination with statins in ACCORD, if the PROMINENT trial of pemafibrate is positive, it could bolster subgroup analyses of ACCORD, suggesting a benefit in patients with high triglycerides and low HDL-C. This would increase competition for omega-3 FAs.
  • In the orphan drug segment, anti-ANGPTL3 monoclonal antibody evinacumab is expected to take share from oral Juxtapid in homozygous familial hypercholesterolemia (HoFH), due to safety and tolerability issues with the latter, but will still be limited by competition with lower-priced PCSK9 inhibitors in eligible patients, assuming evinacumab has orphan pricing. Evinacumab’s HoFH trial also involved inconvenient IV dosing, but subcutaneous dosing is being studied in a Phase II trial in patients with persistent hypercholesterolemia, despite treatment even with PCSK9 inhibitors, and the drug additionally lowers triglycerides, so it could expand to other orphan dyslipidemia indications as well. The antisense drug Waylivra, which targets ApoC-III, may not be approved in the US for familial chylomicronemia syndrome due to safety issues. However, other earlier-stage antisense and RNAi drugs targeting ANGPTL3, ApoC-III, and Apo(a) may avoid these safety issues and have gained large pharma interest, including plans for a CVOT for a broader indication.
  • Given limited budgets for many patients, there will be indirect competition between drugs targeting LDL-C and those targeting triglycerides, if patients are eligible for both, as well as with diabetes drugs that have CV and renal benefits.
  • In the US, different specialties and primary care physicians may use different dyslipidemia guidelines with varying approaches to lipid targets.
  • The overall likelihood of approval of a Phase I dyslipidemia asset is 10.4%, and the average probability a drug advances from Phase III is 65.4%. Dyslipidemia drugs, on average, take 8.1 years from Phase I to approval, compared to 9.8 years in the overall cardiovascular space.
  • There have been 15 licensing and asset acquisition deals involving dyslipidemia drugs during 2014–19. A $1,550m licensing agreement signed in 2019 between Pfizer and Akcea for AKCEA-ANGPTL3-LRx was the largest deal, though only $250m was upfront.
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Contents

Overview
  • Latest key takeaways
Disease Background
  • Definition
  • Patient segmentation
Treatment
  • Treatment guidelines vary across regions
  • Treatment recommendations focus on risk groups
  • Recommendations on specific classes
Epidemiology

Marketed Drugs

Pipeline Drugs

Key Regulatory Events
  • Amarin Seeks EU Fast-Track For Potential Cardiovascular Blockbuster
  • YouTube Video Suggesting Livalo Is Safer Than Other Statins Is Dinged By US FDA
Probability of Success

Licensing and Asset Acquisition Deals
  • Novartis To Pay $9.7bn For The Medicines Company
  • Pfizer Reaffirms CV Disease Commitment With Deal For Akcea's ANGPTL3 Drug
  • Deal Watch: Novartis Opts In On Lipoprotein A Candidate From Akcea
  • Asia Deal Watch: Boost For Esperion's Cholesterol Candidate As Daiichi Brought On Board
  • Novo Carves Deeper Niche Into CV Market With Staten Dyslipidemia Investment
Clinical Trial Landscape
  • Sponsors by status
  • Sponsors by phase
  • Recent events
Drug Assessment Model
  • Cholesterol-lowering drugs
  • Triglyceride-lowering drugs
  • Lipid-lowering and CVOT efficacy data
Market Dynamics

Future Trends
  • New launches and CVOT data will drive growth in the dyslipidemia market over the forecast period
  • Competition among the PCSK9 inhibitors will need to lower net prices more for the class to succeed
  • Price pressures and affordability will continue to be major factors limiting growth
Consensus ForecastS

Recent Events and Analyst Opinion
  • Inclisiran for Dyslipidemia (November 16 & 18, 2019)
  • Vascepa for Dyslipidemia (November 18, 2019)
  • Vascepa for Dyslipidemia (November 14, 2019)
  • Vascepa for Dyslipidemia (November 12, 2019)
  • ARO-ANG3 for Dyslipidemia and ARO-APOC3 for Lipoprotein Lipase Deficiency (September 16, 2019)
  • Inclisiran for Dyslipidemia (September 2, 2019)
  • ETC-1002/Ezetimibe FDC for Dyslipidemia (August 29, 2019)
  • Inclisiran for Dyslipidemia (August 26, 2019)
  • Evinacumab for Dyslipidemia (August 14, 2019)
  • Vascepa for Dyslipidemia (August 8, 2019)
  • Inclisiran for Dyslipidemia (May 18, 2019)
  • ETC-1002 for Dyslipidemia (May 5, 2019)
  • ETC-1002 for Dyslipidemia (March 13, 2019)
  • CER-001 for Dyslipidemia (December 5, 2018)
  • Vascepa for Dyslipidemia (November 10, 2018)
Key Upcoming Events

Key Opinion Leader Insight
  • Interviews with physicians at the ADA conference regarding Vascepa
  • Interview regarding PCSK9 reimbursement with a KOL from a large US payer
Unmet Needs
  • Improved options for statin-intolerant patients
  • A well-tolerated oral drug with LDL-C lowering as good as the current injectable PCSK9 inhibitors when added to a statin
  • Addressing the residual risk remaining in higher-risk patients despite well-controlled LDL-C levels
  • A way to motivate patients to stick with treatment if their lipid levels are elevated
Bibliograpy
  • Prescription information
Appendix

List of Figures
Figure 1: Hypercholesterolemia treatment recommendations in the US
Figure 2: Hypercholesterolemia treatment recommendations in Europe and Japan
Figure 3: Hypercholesterolemia recommendations for specific drug classes
Figure 4: Hypertriglyceridemia recommendations for specific drug classes
Figure 5: Usage of major drug classes
Figure 6: Trends in prevalent cases of dyslipidemia, 2018-27
Figure 7: Overview of pipeline drugs for dyslipidemia in the US
Figure 8: Pipeline drugs for dyslipidemia, by company
Figure 9: Pipeline drugs for dyslipidemia, by drug type
Figure 10: Pipeline drugs for dyslipidemia, by classification
Figure 11: Probability of success in the dyslipidemia pipeline
Figure 12: Licensing and asset acquisition deals in dyslipidemia, 2014-19
Figure 13: Clinical trials in dyslipidemia
Figure 14: Top 10 drugs for clinical trials in dyslipidemia
Figure 15: Top 10 companies for clinical trials in dyslipidemia
Figure 16: Trial locations in dyslipidemia
Figure 17: Dyslipidemia trials status
Figure 18: Dyslipidemia trials sponsors, by phase
Figure 19: Datamonitor Healthcare’s drug assessment summary for dyslipidemia
Figure 20: Dyslipidemia CVOTs in the statin era
Figure 21: Major statin comparison - LDL-C lowering
Figure 22: Ezetimibe - LDL-C lowering
Figure 23: PCSK9 comparison - LDL-C lowering
Figure 24: Inclisiran - LDL-C lowering in Phase III: ASCVD patients (ORION-10, -11) and HeFH (ORION-9)
Figure 25: Heterozygous familial hypercholesterolemia comparison - LDL-C lowering
Figure 26: Omega-3 FA comparison - triglyceride lowering
Figure 27: Fenofibrate - triglyceride lowering
Figure 28: Future trends in dyslipidemia
Figure 29: Inclisiran for Dyslipidemia (November 16, 2019): Phase III - ORION-10 (US)
Figure 30: Inclisiran for Dyslipidemia (November 18, 2019): Phase III - ORION-9 (Heterozygous FH Subjects)
Figure 31: Vascepa for Dyslipidemia (Cardiovascular Disease indication; November 18, 2019): Phase II - EVAPORATE
Figure 32: ARO-ANG3 for Dyslipidemia and ARO-APOC3 for Lipoprotein Lipase Deficiency (September 16, 2019): Phase I - SAD/MAD (AROAPOC31001)
Figure 33: Inclisiran for Dyslipidemia (September 2, 2019): Phase III - ORION-11 (EU)
Figure 34: ETC-1002/Ezetimibe FDC for Dyslipidemia (August 29, 2019): Phase II - 1002-058 (T2DM & Elevated LDLCholesterol)
Figure 35: Evinacumab for Dyslipidemia (August 14, 2019): Phase III - ELIPSE HoFH
Figure 36: Inclisiran for Dyslipidemia (May 18, 2019): Phase II - ORION-3 (OLE)
Figure 37: Vascepa for Dyslipidemia (Cardiovascular Disease indication; November 10, 2018): Phase III - REDUCE-IT
Figure 38: Key upcoming events in dyslipidemia

List of Tables
Table 1: Prevalent cases of dyslipidemia, 2018-27
Table 2: Marketed drugs for dyslipidemia
Table 3: Pipeline drugs for dyslipidemia in the US
Table 4: Dyslipidemia - hypercholesterolemia segment, current and future market dynamics analysis
Table 5: Dyslipidemia - hypertriglyceridemia segment, current and future market dynamics analysis
Table 6: Historical global sales, by drug ($m), 2014-18
Table 7: Forecasted global sales, by drug ($m), 2019-23
Table 8: Inclisiran for Dyslipidemia (November 16 & 18, 2019)
Table 9: Vascepa for Dyslipidemia (November 18, 2019)
Table 10: Vascepa for Dyslipidemia (November 14, 2019)
Table 11: Vascepa for Dyslipidemia (November 12, 2019)
Table 12: ARO-ANG3 for Dyslipidemia and ARO-APOC3 for Lipoprotein Lipase Deficiency (September 16, 2019)
Table 13: Inclisiran for Dyslipidemia (September 2, 2019)
Table 14: ETC-1002/Ezetimibe FDC for Dyslipidemia (August 29, 2019)
Table 15: Inclisiran for Dyslipidemia (August 26, 2019)
Table 16: Evinacumab for Dyslipidemia (August 14, 2019)
Table 17: Vascepa for Dyslipidemia (August 8, 2019)
Table 18: Inclisiran for Dyslipidemia (May 18, 2019)
Table 19: ETC-1002 for Dyslipidemia (May 5, 2019)
Table 20: ETC-1002 for Dyslipidemia (March 13, 2019)
Table 21: CER-001 for Dyslipidemia (December 5, 2018)
Table 22: Vascepa for Dyslipidemia (November 10, 2018)
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