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Lilly Plans New Outcomes Study to Expand Jardiance Label

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Eli Lilly and Company (LLY - Free Report) along with partner Boehringer Ingelheim are planning to conduct a new outcomes study to evaluate the type II diabetes drug Jardiance (empagliflozin) for treatment of patients with chronic kidney disease.

Last year, Lilly received an FDA approval to include cardiovascular risk reduction data from EMPA-REG OUTCOME study on the label of Jardiance. The updated label carrying cardiovascular indication was launched in Jan 2017 while the American Diabetes Association (ADA) has also restructured its diabetes treatment guidelines.

The European Commission had okayed the Jardiance label update for cardiovascular indication in 2016. Notably, Jardiance is the first and only medicine approved to reduce the risk of cardiovascular death in patients with type II diabetes.

Shares of Lilly have underperformed the Zacks classified Large Cap Pharma industry so far this year. The stock has gained 10% compared with the broader industry’s growth of 10.7%.



Plans for new outcomes study is supported by cardiovascular and renal insights from the EMPA-REG OUTCOME research. Although the trial was not primarily designed to assess the effect of Jardiance on kidney outcomes, kidney assessment was part of a pre-specified exploratory analysis plan of additional endpoints. The latest chronic kidney outcomes study would enroll chronic kidney disease patients both with and without type II diabetes.
 
Significantly, Lilly and Boehringer entered into a partnership agreement in 2011 to jointly develop and commercialize a portfolio of diabetes compounds.

Per the company’s press release, approximately two out of three chronic kidney diseases occur as a result of cardiovascular complications. Besides, around 15% of adults in the U.S. are affected by kidney diseases. Hence, there is immense market potential to address the hugely unmet needs of patients affected by chronic kidney diseases in the U.S.

Zacks Rank & Key Picks

Lilly currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in healthcare sector include VIVUS, Inc. , Bayer AG (BAYRY - Free Report) and Regeneron Pharmaceuticals, Inc. (REGN - Free Report) . While VIVUS and Bayer sports a Zacks Rank #1 (Strong Buy), Regeneron carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

VIVUS’s loss per share estimates narrowed from 50 cents to 39 cents for 2017 in last 60 days. The company delivered a positive earnings surprise in each of the trailing four quarters with an average beat of 233.69%.

Bayer’s earnings per share estimates increased from $8.75 to $8.89 for 2017 and from $9.41 to $9.57 for 2018 in the last 30 days. The company delivered a positive earnings surprise in three of the trailing four quarters with an average beat of 10.25%.

Regeneron’s earnings per share estimates increased from $10.16 to $10.52 for 2017 and from $10.90 to $12.10 in the last 60 days. The company delivered a positive earnings surprise in two of the trailing four quarters with an average beat of 0.45%.

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