U.S. FDA panel favors new safety information on AstraZeneca's Onglyza

WASHINGTON, April 14 (Reuters) - AstraZeneca Plc's diabetes drug Onglyza should include new safety information about the risk of heart failure, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday.

The panel voted overwhelmingly that the drug's label should be changed to add information about an increased heart failure risk, but did not express concern about the overall cardiovascular risk profile of the drug.

Panelists were only moderately concerned about an increased risk of death from all causes seen in a sub-group analysis of the data, saying there did not appear to be any uniform cause of deaths in the trial, known as SAVOR.

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)

Advertisement