Glomerular diseases reduce the kidney’s ability to maintain a balance in the blood stream, and causes the kidney to retain toxins and expel proteins and red blood cells from the body. Most glomerular disorders have specific names such as immunoglobulin A (IgA) nephropathy, focal segmental glomerulosclerosis (FSGS), lupus nephritis, and idiopathic membranous glomerulonephritis (IMGN), but are cumulatively referred to as glomerulonephritis (GN). GN describes the inflammation of the membrane tissue in the glomerulus of the kidney that serves as a filter, separating wastes and extra fluid from the blood. Although GN may have different causes, they can lead to chronic kidney disease (CKD), end-stage renal disease, and cardiovascular disease. GN is a common cause of CKD and a threat to public health due to its increasing incidence, poor outcomes, and high associated costs.1 According to Decision Resources Group’s primary research based on 101 U.S. nephrologists2, 15% of their patients' kidney disease can be attributed to GN disorders such as FSGS, IgA nephropathy, IMGN, and lupus nephritis.

Our study, fielded between July 2 – July 13, 20162, revealed that when choosing an agent for the treatment of GN, efficacy in delaying kidney damage and decreasing proteinuria are the two most important attributes to surveyed nephrologists. Hypertension therapies such as angiotensin-converting-enzyme inhibitors (ACEI) or angiotensin II receptor antagonists (ARBs) or calcium channel blockers (CCBs) are regularly prescribed to GN patients as they lower blood pressure (BP) and help reduce the amount of protein that leaks into urine. Nephrotic patients are often prescribed diuretics to reduce high BP in addition to edema, and steroids are typically prescribed to delay worsening kidney damage from GN disorders by reducing inflammation and suppressing the immune system. Frequently prescribed GN medications such as diuretics, ACEIs, ARBs, CCBs, and steroids that help delay kidney disease progression are highly genericized, and the availability of a large array of these inexpensive therapies drive prescriptions. Branded therapies to alleviate GN symptoms do not enjoy significant patient shares according to our study2. Some of these therapies include Mallinckrodt's Acthar, Biogen’s Rituxan, Sandoz’s Cytoxan, Roche’s Cellcept, Novartis’ Myfortic, Astellas Pharma's Prograf, and Pfizer’s Rapamycin/Rapamune.

Although treatment options are available for some types of glomerular diseases, many of these therapies are non-specific, expensive, toxic, and have the potential for major side effects when used long term. According to our study2, the majority of surveyed nephrologists switched GN therapies because the initial treatment was unable to either inhibit GN progression/manifestations, prevent deterioration of kidney function, or normalize clinical symptoms. Furthermore, 25% of nephrologists believed that a lack of effective treatments to slow GN progression was the most common constraint associated with GN patient care. These responses from nephrologists clearly signal the need for new and effective GN therapies. Several therapies are currently in development for the treatment of GN disorders (see table 1). However, surveyed nephrologists’ responses suggest they are not aware of the developments of GN therapies (see figure 1). In most cases, half of the physicians reported low familiarity while a third believed they are moderately familiar with some of these GN therapies. The response from nephrologists is not all that surprising, as most of the therapies in the GN pipeline are in early stage development and GN is a niche market. 9,575 cases of primary GN and 7,176 cases of GN resulting from systemic immunologic disease were identified among 13,712,946 enrollees from 2007-2011, which translated into a prevalence of only 69.8 cases and 52.3 cases, respectively, per 100,000 persons3.

In-depth analysis of factors that drive and constrain GN treatment, as well as brand shares and line of therapy analysis based on GN disorders such as FSGS, IgA nephropathy, IMGN, and lupus nephritis, are presented in Decision Resources Group’s Current Treatment: Glomerulonephritis (US) 2016 insights2.

 

Table 1: GN Pipeline

Compound Company Phase
   AMG-811    Amgen    I
   SHP-627    Shire    I
   ACH-4471    Achillion    I
   AMY-101    Amyndas    I
   AVX-002    Avexxin    I
   Eculizumab    Alexion    II
   Irbesartan + propagermanium    Dimerix    II
   DMX-200    Dimerix    II
   PF-1355    Pfizer    II
   Nefecon    Pharmalink AB    II
   Budesonide    Pharmalink AB    II
   Losmapimod    GSK    II
   Belimumab    GSK    II
   Sparsentan (RE-021)    Retrophin    II
   Fresolimumab    Genzyme/Sanofi    II
   Fostamatinib disodium    Rigel    II
   OMS-721    Omeros    II
   Olmesartan Medoxomil (CS-866)    Daiichi Sankyo    II
   Blisibimod    Anthera    II

 

Figure 1: Familiarity With GN Products in Development

figure1

1KDIGO (Kidney Disease: Improving Global Outcomes) Clinical Practice Guideline for Glomerulonephritis

2Decision Resources Group’s CurrentTreatment® Glomerulonephritis 2016 (US) provides a deep dive on the GN disorder market dynamics. It examines the management of IgA nephropathy, FSGS, lupus nephritis, and IMGN patients from the perspective of 101 U.S. nephrologists. The content provides insight into practice patterns, attitudes and perceptions, and current and projected use of various GN therapies.

3http://www.renalandurologynews.com/nkf-2014-general-news/glomerulonephritis-epidemiology characterized/article/344004/

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