AstraZeneca plc.AZN announced results from an outcomes study, which showed that its blockbuster type II diabetes drug Farxiga can reduce some cardiovascular risks. The DECLARE- TIMI 58 study met the primary efficacy endpoint with Farxiga, a SGLT2 inhibitor, demonstrating non-inferiority of major adverse cardiovascular events (MACE) over placebo.
The phase III cardiovascular outcomes study was carried out in more than 17,000 patients from 33 countries with type-II diabetes who have multiple CV risk factors or established CV disease. The study compared the effect of Farxiga versus placebo in reducing the risk of MACE in such patients.
MACE is a composite endpoint of CV death, non-fatal myocardial infarction or non-fatal stroke. Data from the study showed that Farxiga led to a statistical significant reduction in hospitalization for heart failure or CV death in such patients, thereby meeting one of the two primary efficacy endpoints. Meanwhile, for the other endpoint, though fewer CV events were observed in the Farxiga arm, this did not reach statistical significance.
Detailed data from the study will be presented at the annual session of the American Heart Association to be held in November.
AstraZeneca's shares have gained 8.6% so far this year, outperforming an increase of 7.1% for the industry .
Farxiga recorded sales of $639 million in the first half of 2018, up 36% as the medicine continued to lead the market in terms of volume.
With death from cardiovascular diseases being significantly higher in adults with diabetes compared to those without diabetes, the addition of positive cardiovascular (CV) outcomes on labels of diabetes drugs can give sales a shot in the arm.
If the cardiovascular data from the DECLARE-TIMI 58 study is approved to be included in the label of the drug, Farxiga can cater to a broad range of patients - those with type-II diabetes and at cardiovascular risk. This can further boost sales of the drug.
Other SGLT2 inhibitors available in the market are J&J's JNJ Invokana and Eli Lilly's LLY Jardiance. The label of Jardiance already includes CV risk reduction data from the EMPA-REG OUTCOME study. However, for Invokana, in July, the FDA delayed its decision on J&J's regulatory application looking for approval to include the cardiovascular indication on the label of Invokana. The FDA is now expected to give its decision in October.
AstraZeneca currently carries a Zacks Rank #3 (Hold). A better-ranked large-cap drug stocks is Bristol-Myers Squibb Company BMY which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here .
Bristol-Myers' earnings estimates increased 3.4% for 2018 and 2.7% for 2019 over the last 60 days. The company delivered a positive earnings surprise in three of the trailing four quarters, with an average beat of 6.39%. Shares of the company have risen 13.9% in the past three months.
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
