Skin Toxicity Seen In Other DPP-4 Inhibitors Missing In Januvia – FDA Review
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA requested that Merck conduct an additional study in primates during its review of Januvia (sitagliptin) due to concerns of necrotoxicity based on similar findings seen with other DPP-4 inhibitors.
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Onglyza Stacks Up To Januvia, Bristol/AstraZeneca Say
Onglyza efficacy is competitive with other DPP-4 inhibitors, Bristol-Myers Squibb/AstraZeneca say - Partners say new data on saxagliptin efficacy, presented at EASD in Rome, show competitive profile and are preparing a head-to-head trial with Merck's Januvia. Onglyza and Takeda's alogliptin could join Januvia on the market in the next year, but it's not clear how the new drugs will be differentiated. Heightened scrutiny of diabetes drug safety could help Merck maintain an advantage
Chart: Behind The Approval Letter: A Year Of Drug Review Profiles
Behind The Approval Letter: A Year Of Drug Review Profiles