Boehringer/Lilly's Linagliptin Approved: Can Renal Flexibility Unlock The DPP-4 Market?
This article was originally published in The Pink Sheet Daily
Tradjenta's label supporting use in renally-impaired patients, with no need to adjust dose, could help differentiate the product's safety profile in a competitive space.
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Takeda’s beleaguered Nesina (alogliptin) becomes the fourth DPP-4 inhibitor approved by FDA for diabetes; it remains to be seen whether the drug can find its place in a highly competitive space that continues to be controlled by Merck’s first-to-market blockbuster Januvia.
Boehringer Ingelheim GmbH saw an opportunity to gather more and better head-to-head data for anti-diabetic Tradjenta in its post-market cardiovascular outcomes trial, but FDA couldn't picture a better comparator than gold-standard placebo.
FDA is using the post-marketing study requirements for Boehringer Ingelheim GmbH's Tradjenta (linagliptin) to investigate some of the emerging safety concerns about the DPP-4 inhibitor class.