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Disease Analysis: Dyslipidemia

Disease Analysis: Dyslipidemia

  • May 2020
  • 107 pages
  • ID: 5836954
  • Format: PDF
  • Pharma Intelligence

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The analyst estimates that in 2019, 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, and while declining net pricing in the US has improved access and growth somewhat, sales are still relatively modest, hindered by prior authorization, even though only physician attestation may be needed. The siRNA inclisiran, injected every six months, is slated to be approved in late 2020 and is likely to dominate the segment. Novartis plans to use inclisiran’s more convenient maintenance dosing to pursue administration in healthcare provider offices, with medical rather than pharmacy benefit coverage, including Medicare Part B. Success will depend on whether the drug can avoid prior authorization, and to what extent physicians are willing to adopt the buy-and-bill approach, which may be more suited to larger integrated delivery networks. Inclisiran’s cardiovascular outcomes trial (CVOT) is also designed to show a numerically stronger topline benefit, though the drug is likely to already gain popularity prior to those results. The company is also open to innovative collaborations with healthcare systems outside the US, and has initiated one in the UK.
Oral Nexletol (bempedoic acid), approved in February and April 2020 in the US and Europe respectively, could be limited by modest low-density lipoprotein cholesterol (LDL-C) lowering, particularly on top of statins. However, its fixed-dose combination (FDC) with ezetimibe, Nexlizet, approved a few days after, has better efficacy and could be an important addition, especially in high-need statin-intolerant patients. More real-world data are needed, though, on efficacy of the FDC in patients on higher-dose statins, due to issues in its pivotal trial. In addition, its oral route could lead it to be preferred initially in patients failing statins +/- ezetimibe, especially those who are not too far from goal, and among primary care physicians, 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. In the US, however, both drugs’ initial approvals, pending CVOT results, are in patients with atherosclerotic cardiovascular disease (ASCVD) or heterozygous familial hypercholesterolemia (HeFH). Ultimately, given the large number of hypercholesterolemia patients not meeting goal, either with or without statin intolerance, Nexletol should still be fairly successful despite its modest efficacy, though it still needs to demonstrate positive CVOT results.
In the hypertriglyceridemia segment (including mixed dyslipidemia), a CV label expansion in the US for the omega-3 fatty acid (FA) Vascepa, a formulation of EPA, should drive substantial growth, though with a loss on a patent case in March 2020, there are questions about when generics may enter, pending appeals. On the positive side for the drug, with the failure of Epanova, a mixture of DHA and EPA, physicians may believe that pure EPA is required to reduce CV risk, which should help Vascepa against DHA/EPA generics, though details from Epanova’s trial are still needed to see if there are other explanations. 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. If the data are strong, it could take substantial share from Vascepa.
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 face some competition from the lower-priced PCSK9 inhibitors in eligible patients, assuming evinacumab has orphan pricing. Evinacumab’s HoFH trial also involved inconvenient IV dosing, but SC 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 selected drugs 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 dyslipidemia guidelines with varying approaches to lipid targets.
The overall likelihood of approval of a Phase I dyslipidemia asset is 8.7%, and the average probability a drug advances from Phase III is 60.7%. Dyslipidemia drugs, on average, take 7.6 years from Phase I to approval, compared to 10 years in the overall CV space.

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