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AZ and Takeda drugs should carry heart failure warning

FDA panel claim diabetes drugs Onglyza and Nesina need label updates

FDA headquarters White Oak 

An FDA advisory committee has concluded that two diabetes drugs sold by AstraZeneca and Takeda should have their labelling updated to indicate a link to heart failure.

AZ's Onglyza (saxagliptin) and Takeda's Nesina (alogliptin) are both members of the DPP-4 inhibitor class of diabetes drugs, which is currently headed by Merck & Co's $6bn-a-year Januvia (sitagliptin) brand.

The safety of the two drugs has come under scrutiny after two post-marketing cardiovascular outcome studies - SAVOR in the case of saxagliptin and the EXAMINE trial of alogliptin - revealed possible elevations in cardiovascular risk. Both trials were mandated by the FDA when it published guidelines in 2008 that required all new diabetes drugs to be tested in cardiovascular outcome studies.

In the case of saxagliptin, panellists voted 14 to 1 that labelling for the drug should be updated to reflect an increase in the risk of hospitalisation due to heart failure, as well as information on a trend towards all-cause mortality discussed in an FDA briefing document. The one dissenting vote sought withdrawal of saxagliptin from the market.

However, the majority (13 to 1 with 1 abstention) agreed that the increase risk was small enough to satisfy the FDA's guidance on risk/benefit thresholds for diabetes drugs. AZ said it will conduct further investigation to better understand the signal of hospitalisation for heart failure found in the SAVOR results.

For alogliptin the panel agreed that the data linking the drug heart failure was much weaker but they still voted 13 to 3 in favour of including information on heart failure, with some speculating that this could be a feature of the entire DPP-4 inhibitor class.

With that in mind, attention is fixed on the forthcoming results from the TECOS trial of Januvia, which are due to be presented at the American Diabetes Association (ADA) meeting in June.

The panel concluded that there was no need to restrict prescribing of the drugs, and analysts have suggested that - unless TECOS reveals a more serious safety issue - the deliberations should not put a brake on prescribing of the drug class.

Cangrelor go-ahead

Meanwhile, the FDA's advisory committee also voted 9 to 2 in favour of approving The Medicines Company's injectable anticoagulant cangrelor as an adjunct to percutaneous coronary intervention (PCI), having backed it for preventing blood clots during angioplasty earlier this week. 

The FDA is due to deliver a final decision on cangrelor by June 23. The drug is already on the market in Europe under the Kengrexal trade name.

Article by
Phil Taylor

17th April 2015

From: Regulatory



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