Pharmacy benefit manager Express Scripts has decided to drop Onglyza from its 2016 formulary, after the Type 2 diabetes medication was linked to an increased risk of heart failure. The company is also excluding Kombiglyze XR for the same reason.

Onglyza and Kombiglyze XR are both DPP-4 inhibitors marketed by AstraZeneca. Onglyza contains saxagliptin as its active ingredient, while Kombiglyze XR contains both saxagliptin and metformin. In April, a U.S. Food & Drug Administration (FDA) advisory panel recommended that the drugs’ labels be updated to include information about a potential risk of heart failure, after a clinical trial indicated that patients exposed to saxagliptin were 27% more likely to be hospitalized for heart failure compared to those taking a placebo.

The Onglyza heart failure issues apparently played a role in Express Scripts’ decision to exclude the two drugs from next year’s formulary.

“Onglyza is associated with increased risk of hospitalization due to heart failure,” an Express Scripts spokesperson recently told Medical Marketing & Media. “The market leader, Januvia, showed no risk…With the availability of other DPP-4 inhibitors, the benefits of initiating therapy, particularly with Onglyza, over other agents is less compelling.”

FDA Onglyza Review

The clinical trial that prompted the FDA advisory panel’s recommendation was known as SAVOR. Designed to assess cardiovascular outcomes, the study involved more than 16,000 patients treated with either saxagliptin or a placebo. In addition to the heart failure risk, the study also suggested that saxagliptin was associated with a possible increased risk of death from all causes.

In April, 14 of 15 panelists on the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted to update the label with the heart failure information. One panel member voted to withdraw the drug from the US market.

The FDA has not yet announced any label changes for Onglyza and Kombiglyze XR. However, the agency usually does follow the recommendations of its advisory panel.

Where You Hospitalized with Heart Failure While Taking Onglyza? Obtain a Legal Review Today.

You may be entitled to compensation if you or a loved one were hospitalized with heart failure while taking Onglyza. To learn more about filing an Onglyza lawsuit, please call Bernstein Liebhard LLP at 877-779-1414 to schedule a free, no-obligation legal review.

Published August 4, 2015 by