FDA panel backs safety updates for AstraZeneca, Takeda drugs

[April 15, 2015] By Toni Clarke

WASHINGTON (Reuters) - AstraZeneca Plc's diabetes drug Onglyza and Takeda Pharmaceutical Co.'s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday.

Heart failure is a condition in which the heart cannot pump enough blood to meet the body's needs. It can be caused by coronary artery disease, high blood pressure, diabetes or obesity, according to the Mayo Clinic.

The panel reviewed safety data on AstraZeneca's Onglyza and Takeda's Nesina. The drugs belong to a class known as DPP-4 inhibitors which also includes Merck & Co.'s Januvia. Januvia data from a trial known as TECOS will be presented at a scientific meeting in June.

The studies were requested by the FDA as part of a broader investigation into the safety of diabetes drugs. In December 2008, the agency issued guidance requiring companies to conduct studies to show the drugs did not increase cardiovascular risk.
 

The panel found that neither Onglyza nor Nesina increased the risk of cardiovascular death, stroke or heart attack. But data showed a statistically significant increase in the risk of heart failure with Onglyza and an increased risk with Nesina that did not reach statistical significance.

Some panelists said that even though the heart failure risk seen with Nesina was modest, they suspect the risk will turn out to be a DPP-4 class effect and therefore worth including.

The panel did not recommend any restrictions on prescribing the drugs. AstraZeneca's U.S. shares rose 3.2 percent. Takeda's shares closed down 0.67 percent before the vote was announced. Merck's shares rose 1.8 percent.

"Given the absence of a serious safety issue for either Onglyza or Takeda's Nesina suggests that, barring an overtly negative signal in TECOS, growth of the DPP-4 class is likely to continue without a meaningful change in current prescribing trends," Leerink analyst Seamus Fernandez said in a research note.

A preliminary FDA review of Onglyza published on Friday found an increase in the rate of death from all causes. Panel members said they were moderately concerned about the signal but said their concern was muted by the fact that the causes of death were varied and lacked any common theme.

Onglyza, known also as saxagliptin, was approved in 2009. Nesina, or alogliptin, was approved in 2013. The FDA is not obliged to follow the advice of its advisory panels but typically does so.

(Reporting by Toni Clarke; Editing by Will Dunham and Andrew Hay)

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