FDA committee recommends label change for Onglyza

Onglyza
Onglyza

An FDA advisory committee's 13-1 vote that AstraZeneca's diabetes medication Onglyza (saxagliptin) has an acceptable cardiovascular risk has not relieved pressure on the DPP-IV class of medications.

Although the FDA panel voted that Onglyza's cardiovascular risk was acceptable, it also voted that the drug's label should include its association with a greater risk of hospitalization for heart failure—the study the panel reviewed for this decision showed a 27% greater risk among patients who took Onglyza as opposed to those who received a placebo. Reviewers also noted that the study focused on patients who had a high risk of heart disease, meaning the drug may not be off-limits for a wider patient population.

Tuesday's vote has only increased investor focus on Merck's Tecos study, which concentrates on the cardiovascular risk profile that may be associated with its DPP-IV inhibitor Januvia (sitagliptin). Sanford C. Bernstein analyst Dr. Tim Anderson wrote that the Tecos study will probably help the FDA determine if the elevated risk of heart failure associated with AstraZeneca's Onglyza is characteristic of the DPP-IV class as a whole or if it is limited to this one drug.

Leerink Partners analyst Seamus Fernandez said in a Tuesday research note that the panel's vote was not a surprise, but he did note that while the vote indicates no serious level of concern about the drug's effects, it offers competitors a talking point if Merck, Eli Lilly and Takeda can tell physicians that their heart safety studies do not show a link between their medications and hospitalization for heart failure.

Merck is expected to release the Tecos data at the American Diabetes Association annual meeting in June.

The FDA panel also reviewed Takeda's DPP-IV inhibitor Nesina (alogliptin) and voted that the DPP-IV inhibitor had an acceptable cardiovascular risk profile. Anderson wrote that while some panelists voted to update Nesina's label, they generally were not bothered by Nesina's cardiovascular results until considered alongside Onglyza's profile. Thirteen panelists voted that the label should include safety information when Onglyza's information was provided as additional context but three committee members said no revision was necessary. Fernandez wrote in a separate research note that “predicting the label update for Nesina is challenging based on the relatively small number of events and relatively dubious signal” for heart-failure hospitalizations.

AstraZeneca said in a statement that it will study Onglyza's increased risk for heart failure hospitalization.