FDA Finds AZ’s Onglyza Could Carry Heart Risks

April 16, 2015

The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee met Tuesday to review the safety of DPP4 inhibitors, a class of diabetes drug the FDA first approved in 2009, according to briefing materials released by the agency last week.

The agency has already flagged Onglyza after a postmarket trial showed a 27 percent increase in first hospitalizations for heart failure in the treatment arm taking the drug. The other drugs in the class are Merck’s Januvia (sitagliptin), Takeda’s Nasina (alogliptin) and Boehringer Ingelheim’s Tradjenta (linagliptin).  

While the Onglyza postmarket trial showed unusually high rates of heart failure, a similar study of Nasina did not bear out those fears. Merck still has not unblended the results of a long-term cardiovascular outcomes trial and thus can’t say how Januvia stacks up, spokeswoman Pamela Eisele said. 

The FDA issued guidance in December 2008 to assist companies in evaluating the cardiovascular risks associated with newer diabetes drugs in premarket and postmarket studies.

The FDA says it is also concerned about the number of trial patients who died of causes other than heart failure.

Read the FDA’s preliminary review of Onglyza at www.fdanews.com/04-10-15-Onglyzareview.pdf. — Lena Freund