Johnson & Johnson (JNJ - Free Report) presented new data from a large CANVAS outcomes program on its type II diabetes drug, Invokana (SGLT2 inhibitor), demonstrating an improved renal outcome. The data was presented at the annual meeting of the American Heart Association Scientific Sessions in California and published in the Circulation.
So far this year, Johnson & Johnson’s share price has increased 21.1%, comparing favorably with the 14.4% rally of the industry it belongs to.
This new analysis of CANVAS showed a reduction in the risk of the composite renal endpoint in both patient groups — with a history of CV disease (secondary prevention) and those with only risk factors for CV disease (primary prevention). Also, Invokana demonstrated reduction in the risk of hospitalization due to heart failure (HHF) in both patient groups. No new adverse events were reported during this additional analysis.
We remind investors that in June, the company reported data from the CANVAS program, which demonstrated that Invokana was successful in reducing the risks of cardiovascular (CV) outcomes in type II diabetes patients, who have established cardiovascular (CV) disease or are at a risk for CV disease. Invokana reduced major adverse CV events or MACE by 14% compared with placebo. MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke. However, the study also showed that the drug increased the risk of amputations.
Last month, J&J submitted a supplemental new drug application (sNDA) to the FDA for the label expansion of Invokana to include the cardiovascular indication based on the data from the CANVAS program.
Many pharma companies are working hard to get the labels of their diabetes medicines updated to include the cardiovascular benefits. With death from cardiovascular diseases being significantly higher in adults with diabetes compared with those without it, the addition of positive CV outcomes on labels of diabetes drugs can give sales a shot in the arm.
Eli Lilly & Company (LLY - Free Report) received both FDA and EU approvals last year to include the CV risk reduction data from the EMPA-REG OUTCOME study on the label of Jardiance. Additionally, in August, Novo Nordisk’s (NVO - Free Report) Victoza (liraglutide) was approved by the FDA for a new indication to reduce the risk of major adverse cardiovascular (CV) events in adults with type II diabetes and established CV disease.
However, in May, Merck & Co., Inc. (MRK - Free Report) was denied an approval by the FDA to include cardiovascular outcomes data from the TECOS trial on the labels of its DPP-IV inhibitor, Januvia (sitagliptin) and other medicines containing Januvia.
AstraZeneca’s Bydureon also failed to reduce the cardiovascular risk in a phase IIIb/IV cardiovascular outcomes study, EXSCEL.
Johnson & Johnson carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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