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J&J's Invokana Lowers Heart Issues, Raises Amputation Risk

Johnson & Johnson JNJ announced data from a large CANVAS outcomes program, which demonstrated that its type II diabetes drug Invokana (canagliflozin) was successful in reducing the risks of heart attacks and strokes. However, the study also showed that the drug increased the risk of amputations.

The data were presented at the annual meeting of the American Diabetes Association and published by the New England Journal of Medicine.

The CANVAS program comprised two, nearly-identical large outcomes studies called CANVAS and CANVAS-R.

Data from the CANVAS CV outcomes study showed that its SGLT2 inhibitor, Invokana reduced major adverse CV events or MACE by 14% versus placebo in diabetes patients at risk for or with a history of CV disease. MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke.

While the risk of CV death was reduced by 13% that of nonfatal MI and nonfatal stroke  was reduced by 15% and 10%, respectively. The data also showed that Invokana reduced risk for hospitalization for heart failure (HHF). Meanwhile, the study also demonstrated the CV safety of Invokana and superiority compared to placebo

On the other hand, CANVAS-R study showed that Invokana was beneficial in delaying progression of albuminuria and reducing the risk of renal death and renal replacement therapy.

However, an increased risk of amputations was identified in both the studies, which was almost double that of placebo. The observation was consistent with the black boxed warning on Invokana’s label on the increased amputation risk associated with the use of the drug.

J&J’s shares have outperformed the Zacks classified Large Cap Pharma industry so far this year. The company’s shares have gained 14.4% compared with the industry’s gain of 10.8%.

Many pharma companies are working hard to get the labels of their diabetes medicines updated to include their cardiovascular benefits.

With death from cardiovascular diseases being significantly higher in adults with diabetes compared to those without diabetes, the addition of positive CV outcomes on labels of diabetes drugs can give sales a shot in the arm. Almost all these companies are conducting CV outcomes studies to evaluate the cardiovascular benefits of their diabetes drugs. While some diabetes drugs have been successful in lowering CV risk in high-risk diabetic patients in outcomes studies, some have not.

Eli Lilly & Company LLY received FDA approval last year to include CV risk reduction data from the EMPA-REG OUTCOME study on the label of Jardiance. The updated label including the cardiovascular indication was launched in Jan 2017 while the American Diabetes Association (ADA) has also updated its diabetes treatment guidelines. The European Commission also approved the Jardiance label update for the cardiovascular indication in 2016. The company expects the inclusion of this data to improve sales of Jardiance. On the first quarter conference call, Lilly said that since the launch of the CV indication and ADA’s addition of Jardiance to its treatment guidelines, its new-to-therapy volume has increased 75%.

However, last month, Merck & Co., Inc. MRK was denied approval by the FDA to include cardiovascular outcomes data from the TECOS study on the labels of its DPP-IV inhibitor Januvia (sitagliptin) and other medicines containing Januvia.

AstraZeneca plc’s AZN Bydureon also failed to reduce cardiovascular risk in a phase IIIb/IV cardiovascular outcomes study, EXSCEL.

J&J carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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