FDA panel endorses new heart failure warnings for key AstraZeneca diabetes medicine

Publicado por en 20 Abr, 2015 en Noticias | Sin comentarios

DPP-4 inhibitors, such as AstraZeneca’s Onglyza® (saxagliptin) and Takeda’s Nesina® (alogliptin), may be associated with an increased risk of heart failure, according to an FDA panel.

In 2008, the FDA issued guidance requiring companies that manufacture diabetes drugs to show that the drugs do not increase cardiovascular (CVD) risk.

When the FDA’s advisory committee looked specifically at Onglyza and Nesina, they found that neither of the drugs increases the risk of CVD death, stroke, or heart attack. However, there was a statistically significant increase in the risk of heart failure associated with Onglyza, as well as an increase in all-cause mortality that concerned FDA staff.

Threfore, an advisory panel to the U.S. Food and Drug Administration voted Tuesday to recommend the agency require drugmaker AstraZeneca to change the labeling of its diabetes medication Onglyza to add safety information to reflect a heightened risk for heart failure associated with its use.

The FDA’s Endocrinologic and Metabolic Advisory Committee voted 14-1 in favor of changing the drug’s label in light of results from a post-marketing study that found Onglyza was associated with a 27% increase in hospitalizations for heart failure as well as a higher risk of all-cause mortality.

The panel stopped short of recommending stronger actions, such as restricting distribution of the drug or withdrawing it from the market. It found the results of the study represented the drug’s cardiovascular risk profile was acceptable, but called for additional study on the potential long-term effects.

Onglyza is a member of a class of diabetes drug known as DPP-4 inhibitors, which are used to control blood glucose levels in type 2 diabetes patients. Such drugs have been required by the FDA since 2008 to undergo studies examining safety after concerns were raised over a possible link between diabetes drugs and a higher risk for heart failure.

Other DPP-4 inhibitors include the Takeda Pharmaceuticals diabetes drug Nesina® (alogliptin), the drug Tradjenta® (linagliptin) from Eli Lilly & Co. and Boehringer Ingelheim, and Merck’s Januvia® (sitagliptin), which accounts for the largest market share with sales totaling $3.9 billion in 2014.

Merck is expected to release results of its Januvia study in the coming months. In a recent research note, Seamus Fernandez, an analyst at the investment research firm Leerink Partner LLC, wrote that the results of Merck’s study could have large implications for Onglyza. He said that if Januvia showed it did not carry the same types of health risks found in Onglyza, the result could be a 50% drop to its sales, which reported worldwide sales totaling $378 million in 2013, according to the company’s financial statements.

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