Despite the demonstrated links between lower limb amputations, kidney failure, osteoporosis and acute pancreatitis, Johnson & Johnson has followed through with its earlier plans to expand the market for its controversial diabetic medication, Invokana. This month, the New Jersey-based pharmaceutical giant filed a supplemental new drug application (SNDA) to the Food and Drug Administration for approval to add a new claim to the label: Invokana reduces the risk of heart attacks and strokes.

These new claims are based on results of the recent CANVAS trial, results of which were published last summer in the New England Journal of Medicine. The study was funded by J&J subsidiary Janssen Pharmaceuticals. It found that patients suffering from Type 2 diabetes with an elevated risk of heart disease were at lower risk for major cardiovascular events (i.e., heart attack and stroke), but were at greater risk of lower limb amputations (generally at the toe or foot).

Complications associated with diabetes include nerve damage (peripheral neuropathy) and poor blood circulation, both of which make the patient more likely to develop ulcers of the feet. This in turn leads to serious tissue and bone damage, which ultimately require amputation. One of the major contributing factors to these conditions is chronically high blood sugar levels – a condition that ironically, Invokana was intended to address. Another cause is kidney disease – and the association between Invokana and kidney damage is well-established.

If Johnson & Johnson’s application receives FDA approval, the company will be able to start marketing Invokana to physicians and insurance companies as a preventive treatment for heart conditions. It also means that Invokana will be in a better position to compete with other SGLT2 inhibitors – primarily, Jardiance (empagliflozin), a product of Eli Lilly and Boehringer Ingelheim, which has already received FDA approval for cardiovascular indications based on the results of a 2015 clinical study (EMPA-REG). Another drug in this class, AstraZeneca’s Farxiga, is still undergoing trials for cardiovascular outcomes.

Unfortunately for J&J, the amputation risk remains for Invokana. This risk association has not been demonstrated with other SGLT-2 inhibitors, and could put a damper on the company’s ambitions to dominate the market for drugs in the gliflozin class. J&J’s Janssen division is attempting to gain an advantage over its competitors in a new study that will attempt to demonstrate Invokana’s effectiveness in reducing the progression of renal impairment in diabetic patients – which seems odd, considering that the drug has already been linked to kidney damage. At the same time, AstraZeneca and Pfizer are conducting their own studies in this area.

In the end, these studies are not about patients – they are about profits. According to analysts, FDA approval of Jardiance for cardiovascular outcomes means that sales of that drug could reach $1.7 billion over the next seven years. Furthermore, since AstraZeneca was first out of the gate – and Jardiance is not linked to increased amputation risk – Johnson & Johnson’s Invokana will be at a distinct market disadvantage.  

K.J. McElrath is a former history and social studies teacher who has long maintained a keen interest in legal and social issues. In addition to writing for The Ring of Fire, he is the author of two published novels: Tamanous Cooley, a darkly comic environmental twist on Dante's Inferno, and The Missionary's Wife, a story of the conflict between human nature and fundamentalist religious dogma. When not engaged in journalistic or literary pursuits, K.J. works as an entertainer and film composer.