Safety of diabetes drug Onglyza probed

The FDA is to investigate the safety of AstraZeneca’s diabetes drug Onglyza after links to heart failure emerged.

The US regulator has requested clinical trial data from the company after a study published in the New England Journal of Medicine (NEJM) found an increased rate of hospitalisation for heart failure in patients using saxagliptin (marketed as Onglyza and Kombiglyze XR) compared to placebo.

The probe is bad news for AstraZeneca, which is trying to grow its share of the type 2 diabetes market. Onglyza is in the DPP-4 inhibitor class, and saw its sales rise 17% last year to $ 378 million.

Merck’s Januvia (sitagliptin) is the market leader in the DPP-4 class, with 2013 sales of just over $4 billion. However its sales fell back slightly last year, possibly influenced by another safety scare.

The DPP-4 drugs and GLP-1 agonist drugs such as AstraZeneca’s Byetta have also been suspected of increasing the risk of pancreatitis, but an EMA-led review concluded in August there was no firm evidence of this link.

The new NEJM study, funded by AstraZeneca and BMS, did not find Onglyza increased rates of death or heart attack or stroke, but did suggest a link with increased heart failure rates. Regulators have become especially wary of diabetes drugs since serious safety concerns about GSK’s diabetes treatment Avandia emerged in 2007.  Avandia was eventually withdrawn from the market in Europe and its use heavily restricted in the US, after a clear link was apparently established with raised risk of heart attack and stroke.  However the recently published large-scale RECORD trial found no such links, causing the FDA to lift many of its restrictions last November.

The FDA says its review of Onglyza is in line with a new tighter policy for assessing the safety of diabetes drugs which was introduced in 2008.

AstraZeneca is expected to submit the trial data by early March 2014, after which the FDA will conduct a thorough analysis and publicly report its findings.

The FDA said it considered the NEJM study to be ‘preliminary’ and urged patients not to stop taking the drug and advised doctors to continue following prescribing recommendations.

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