LONDON, Apr 7 (APM) - Merck & Co on Friday said the U.S. Food and Drug Administration has rejected its application to include cardiovascular outcomes data on the indications for its sitagliptin family of diabetes medicines.
The U.S. Firm said in a statement that the FDA sent a complete response letter regarding Merck's attempt t include data from the TECOS trial on the prescribing information of Januvia (sitagliptin) Janumet (sitagliptin+ metformin) and Janumet XR.
The move is a blow to Merck, which is looking to use data from the TECOS trial to convince the healthcare community that its DPP-4 inhibitor does not pose a risk of increased cardiovascular events. Heart failure was a complication that showed up unexpectedly in a similar study of another DPP-4 inhibitor, AstraZeneca's Onglyza (saxagliptin) in the SAVOR study
Merck posted data from the TECOS trial in June 2015 that it said demonstrated equivalent risk of cardiac event to placebo (APMMA 42832 ).
The trial enrolled 14,735 patients who were randomised between sitagliptin and a placebo. Patients were type 2 diabetics who already had cardiovascular disease, at the cardiac, cerebral or peripheral level.
After 2.8 years' monitoring, risk of cardiovascular death, myocardial infarction (MI), stroke or hospitalisation for unstable angina stood at 11.4% in the sitagliptin group and 11.6% in the placebo group.
Risk of hospitalisation for heart failure was identical in the two groups: 3.1%. All-cause mortality was also similar: 7.5% and 7.3% in the sitagliptin and placebo groups, respectively. The same applied for cardiovascular mortality: 5.2% and 5%.
Shortly after these data were posted, German drugs bulletin Arznei-Telegramm accused Merck study authors of putting a positive spin on sitagliptin trial data, focusing on reassuring cardio safety figures while brushing over potential pancreatitis and other safety signals for the diabetes drug (APMMA 43364 ).
Merck has previously had trouble convincing authorities of the value of the TECOS trial. In October last year German health technology assessment (HTA) body IQWiG concluded that the study was not helpful for its assessment, of Janumet (APMMA 49879 ).
Merck said it is reviewing the FDA letter and will discuss next steps with the regulator.
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