The U.S. Food & Drug Administration (FDA) has given the thumbs down to a combination Type 2 diabetes medication being developed by AstraZeneca that would combine the active ingredients found in Onglyza (saxagliptin) and Farxiga (dapagliflozin). A statement from the drug maker did not say why the FDA rejected the medication, but did note that agency reviewers were seeking more clinical trial data.
“This includes clinical trial data from ongoing or completed studies and may require information from new studies,” the statement said. “AstraZeneca will work closely with the FDA to determine the appropriate next steps for the NDA (New Drug Application) and remains committed to the development of the saxagliptin/dapagliflozin fixed-dose combination.”
AstraZeneca markets both Onglyza and Farxiga. Launched in 2009, Onglyza is a DPP-4 inhibitor that belongs to a class of widely-used Type 2 diabetes drugs called incretin mimetics. Other medications in this class include Januvia, Janumet, Byetta, and Victoza.
In February 2014, the FDA announced that it was investigating a potential association between Onglyza and heart failure, after the results of a clinical trial indicated that patients using saxagliptin were 27% more likely to be hospitalized with heart failure compared to patients taking a placebo. The trial, known as SAVOR-TMI, involved 16,492 Type 2 diabetes patients with established cardiovascular disease or at high risk of cardiovascular disease. In addition to the heart failure risk, the study indicated that saxagliptin patients were at an increased risk of all-cause mortality.
In April, the FDA convened a panel of outside medical advisors to review data from the SAVOR-TIMI trial, at which time the members voted 14-to-1 to recommend that new information about heart failure be added to the labels of Onglyza and other drugs containing saxagliptin. The FDA is not required to enact the recommendation, but it generally does follow the opinions of its outside advisory panels.
The labels for Onglyza and other incretin mimetics currently include warnings about a possible increased risk of pancreatitis. In 2013, the FDA also investigated this class of medications because of concerns that their use might be linked to the development of pancreatic cancer. While the FDA has been unable to conclude that Onglyza and other incretin mimetics cause pancreatic cancer, it is continuing to monitor this issue.
In September, the FDA also warned that Onglyza and other DPP-4 inhibitors had been linked to dozens of reports of severe joint pain. The affected patients began experiencing discomfort from 1 day to years after they started taking a DPP-4 inhibitor, and symptoms were usually relieved within a month of ceasing treatment. Of the 33 cases reported to the FDA, five involved Onglyza.
Bernstein Liebhard LLP is now offering free legal reviews to alleged victims of Onglyza and heart failure. To learn if you might be eligible to file a claim against AstraZeneca, please call to discuss your potential Onglyza lawsuit with a member of our legal staff.