The results of the 10,142-patient Invokana study were unveiled on June 12, 2017, at the annual meeting of the American Diabetes Association, and the results support the FDA requirement of a black box warning concerning amputations, which was implemented in May of 2017. Approved in March 2013, Invokana® (canagliflozin) is an SGLT2 Inhibitor used to treat adults with Type 2 diabetes, manufactured by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson.
SGLT2 inhibitors prevent high blood sugar by helping the kidneys remove excess sugar through urine elimination. In the study unveiled before the American Diabetes Association, Invokana was shown to decrease the risk of cardiovascular events such as heart attack or stroke, by 14 percent.
This is the same benchmark exhibited by Jardiance in its 2015 7,000-patient study. However, the similarities between the two drugs end there. The recent Invokana study also revealed a two-fold increase in the rate of leg, foot and toe amputations.
Inexplicably, Jim List of Janssen overlooked the amputation data and focused exclusively on the cardiovascular risk data by stating that “[w]e think, looking at the data – the size, the breadth, the duration of trials – we think these are very strong, very clinically important, and we look forward to filing this with the FDA and other regulatory agencies around the world.” Really? Why would any responsible pharmaceutical company “look forward” to filing a study with the FDA and “other regulatory agencies around the world” that reveals its drug causes a twofold increase in the rate of amputations of the lower extremity?
Clearly, List is only trying to protect the substantial revenue stream provided to Janssen by Invokana, which has been a blockbuster drug for several years. According to FiercePharma, Invokana is one of the top 10 highest selling diabetes drugs in 2016, with more than $1 billion in sales. Furthermore, it is the only SGLT2 diabetes medication in the top 10.
As noted by Matthew Herper of Forbes Magazine, “[t]he result of the 2017 Invokana study is a blow to J&J, and a boost to rivals Eli Lilly and Boehringer Ingelheim, [the makers of Jardiance], which has been shown to reduce the risk of cardiovascular death but does not appear to carry the amputation risk.” Indeed, the risk of amputation seems to be unique to Invokana among the entire class of SGLT2 inhibitors, which includes AstraZeneca PLC’s Farxiga and Xigduo XR and Boehringer Ingelheim GmbH and Eli Lilly and Co.’s Jardiance and Glyxambi. As noted by Evercore ISI analyst Umer Raffat, “[t]he amputation imbalance is a headwind for JNJ in particular.”
Dr. John Buse, the chief of endocrinology at UNC-Chapel Hill has stated “[p]ersonally, I would much rather have a small heart attack than lose a toe, and I think I would much rather have a heart attack than lose a leg.” (Herper, Matthew, “J&J Drug Prevents Heart Attacks at Cost of Amputated Toes,” Forbes Magazine, June 12, 2017). It is sad commentary that an individual with diabetes may be forced to choose between the loss of a limb or a slightly reduced risk of heart attack in order to treat diabetes.
The Invokana study of 2017 and the Jardiance study of 2015 have revealed that these SGLT2 inhibitors carry a cardiovascular benefit, but the Invokana study has now revealed that Invokana has an increased risk of amputation. Thus far, no one can explain why these two drugs carry a cardiovascular benefit, or why Invokana carries an amputation risk. As noted by Matthew Herper of Forbes Magazine both “drugs decrease blood pressure and blood sugar, both good for the heart, but that can’t explain the whole benefit. Perhaps the SGLT2 thickens the blood leading it to pool in the foot.” Some of these questions may be answered by the next big clinical trial of Farxiga, which involves 17,150 patients and is funded by AstraZeneca.
The 2017 Invokana study will be published in the New England Journal of Medicine. It should be noted that the study was funded by Johnson & Johnson. If you need more information on the Invokana Litigation contact Allison Hunnicutt, a lawyer in our firm’s Mass Torts Section at 800-898-2034 or email Allison.Hunnicutt@beasleyallen.com.
Sources: Forbes Magazine, FirecePharma, and Law360
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