Sitagliptin Shows No Increased Cardiovascular Risk In Merck’s TECOS Trial
This article was originally published in The Pink Sheet Daily
Based on results of the TECOS study, Merck will seek approval to include additional safety information in the labeling for Januvia and Janumet.
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Merck got a complete response letter from FDA on a cardiovascular risk-reduction claim for the DPP-4 inhibitor based on TECOS trial data. This places Januvia/Janumet behind Jardiance, which already has a CV safety label claim, and Victoza, which awaits an FDA decision on a supplemental NDA filed last October.
Keeping Track: Teva's Austedo Clears US FDA, Merck Sitagliptin CV Outcomes Labeling Draws Complete Response
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Meta-analysis published in JAMA suggests registry-based studies could be alternative to large cardiovascular outcomes trials.