AstraZeneca, Takeda Diabetes Drugs Should Warn of Risk

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The cardiovascular risk of diabetes drugs made by AstraZeneca Plc and Takeda Pharmaceutical Co. is acceptable, though the drugs’ labels should include safety information on heart failure, U.S. advisers said.

Most members of a Food and Drug Administration advisory panel voted Tuesday to recommend the agency add data from trials on the heart effects to the labels of AstraZeneca’s Onglyza and Takeda’s Nesina. They also voted that the drugs’ cardiovascular risk is acceptable.

The panel met to discuss data showing both drugs increased the risk of hospitalization from heart failure, though neither went above the 30 percent increased risk defined as unacceptable by the trials. The panel also discussed data from a clinical trial that showed patients taking Onglyza were more likely to die than those who received a placebo.

An FDA analysis didn’t find a reason for the higher number of people on Onglyza who died, compared with the placebo, leaving the panel unconvinced that the drug raised risk of death.

Fourteen of 15 members of the panel voted to recommend that the agency add data from a trial on Onglyza’s heart effects to the drug’s label. Thirteen of 16 panel members voting agreed to recommend Takeda do the same for Nesina’s label with its trial data.

The panel also voted 13-1, with one abstention, that Onglyza’s cardiovascular risk was acceptable and 16-0 that Nesina’s risk is also acceptable.

Predicting Risk

Heart failure “seems like a real signal, but I think it’s occurring in a setting where we can more or less predict the people who would be at risk,” Morris Schambelan, a panel member and professor emeritus of medicine at the University of California at San Francisco, said during the discussion on Onglyza.

Other panel members expressed confidence that at-risk patients could be identified, and they encouraged AstraZeneca to come up with a plan to manage such patients.

Onglyza and Nesina are in a class of drugs known as DPP-4 inhibitors that includes Merck & Co.’s Januvia.

A clinical trial of Takeda’s drug didn’t find increased risk of deaths, according to an FDA staff report. Merck hasn’t yet released results of its heart-risk trial.

The FDA has required cardiovascular trials for diabetes drugs since 2008. Onglyza’s risk of hospitalization for heart failure was reported in 2013, and the link to more deaths came to light when the FDA staff did their own analysis of the data in a report before Tuesday’s meeting.

Onglyza, approved in 2009, generated $820 million in sales last year for London-based AstraZeneca. Nesina, approved in 2013, brought in $403 million in fiscal 2014 revenue for Osaka, Japan-based Takeda, according to data compiled by Bloomberg.

(Corrects vote on Takeda label in fifth paragraph.)
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