Diabetic Complications: Retinopathy, Neuropathy, Nephropathy

Pharmacor -- September 2007

  Introduction:

A large share of the cost burden of diabetes can be attributed to the microvascular complications of diabetes (retinopathy, neuropathy, and nephropathy). Unfortunately, few agents are available that address the underlying causes of these complications. As a result, the treatment of diabetic complications holds significant sales potential for any emerging, innovative therapies.

  Questions Answered in This Report:

Off-label use of the vascular endothelial growth factor (VEGF) inhibitor bevacizumab (Genentech/Roche/Chugai’s Avastin) for diabetic retinopathy has risen in recent years, despite the lack of a specifically approved ophthalmological formulation. How will the first VEGF inhibitor developed specifically to treat diabetic retinopathy fare against the significantly cheaper bevacizumab?

Following disappointing clinical trial results for ruboxistaurin (Eli Lilly’s Arxxant) and the company’s decision to suspend development of the drug for diabetic neuropathy, prescribers are eager to find agents that treat the underlying pathophysiology of the disorder. What agents are in development to treat diabetic neuropathy? How will they perform in the market?

Current treatment of diabetic nephropathy focuses on glycemic and blood pressure control, but guideline targets are difficult to achieve in practice. Several disease-modifying agents are in development. What are the most promising compounds, and how will they be integrated into treatment?

  Scope:

Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

Primary research: 39 country-specific interviews with diabetologists, endocrinologists, neurologists, nephrologists, and ophthalmologists

Epidemiology: Prevalence of diabetic retinopathy (proliferative and nonproliferative), diabetic neuropathy, and diabetic nephropathy (microalbuminuria, microalbuminuria, and end-stage renal disease).

Population segments in market forecast: diabetic retinopathy, diabetic neuropathy, and diabetic nephropathy.

Emerging therapies: Phase I: 1 drug; Phase II: 3 drugs; Phase III: 9 drugs; preregistration: 3 drugs.

Market forecast features: Using a proprietary patient flow model incorporating mortality, we forecast population sizes and drug sales across the three markets (diabetic retinopathy, neuropathy, and nephropathy) through 2016.

Alternative market scenarios: (1) head-to-head studies demonstrate that bevacizumab is comparable to ranibizumab; (2) ranirestat is shown to be superior to standard therapy in diabetic neuropathy; (3) aliskiren demonstrates favorable Phase III data in preventing the development of diabetic nephropathy; (4) sulodexide studies demonstrate efficacy in preventing progression to macroalbuminuria.