Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

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.

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.

Related Content

Topics

UsernamePublicRestriction

Register

PS072263

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel