Boehringer/Lilly's Linagliptin Approved: Can Renal Flexibility Unlock The DPP-4 Market?
This article was originally published in The Pink Sheet Daily
Executive Summary
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.
You may also be interested in...
Takeda Treads Carefully With DPP-4 Late-Arrival Nesina, Plans Summer Launch
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.
FDA Seeks Clarity On DPP-4 Class Safety Signals With Linagliptin Post-Market Requirements
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.
BI’s Tradjenta Lesson: Don’t Try To Use CV Trial To Score Head-To-Head Efficacy Evidence
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.