Please login to the form below

Not currently logged in
Email:
Password:

Lilly/Boehringer diabetes drug approved

The US Food and Drug Administration has granted marketing approval to a type 2 diabetes drug developed through a partnership between Lilly and Boehringer Ingelheim

The US Food and Drug Administration (FDA) has granted marketing approval to a type 2 diabetes drug developed through a partnership between Lilly and Boehringer Ingelheim.

Approval of the drug, Tradjenta (linagliptin), is the first regulatory milestone in the companies' worldwide diabetes alliance since the partnership was formed in January of this year. 

Tradjenta is indicated to lower blood sugar in adults when used in conjunction with a diet and exercise programme. The drug can be used as monotherapy or in combination with other commonly prescribed diabetes medications. 

The therapy increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4 (DPP-4). It is the first of the DPP-4 inhibitors to be approved at one dosage strength (5 mg, once daily), with no dose adjustment necessary in patients with kidney or liver impairment.

The approval was based on a New Drug Application (NDA) that contained data from eight double-blind, placebo-controlled clinical studies involving about 3,800 patients with type 2 diabetes.

Tradjenta is currently under regulatory review in the EU and Japan. The product will be available as a tablet that can be taken with or without food.

"This approval provides another treatment option for the millions of Americans with Type 2 diabetes," said Mary Parks, director of the Division of Metabolism and Endocrinology Products in the FDA's Center for Drug Evaluation and Research. "It is effective when used alone or when added to existing treatment regimens."

4th May 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Brandcast Health

Brandcast Health is a digital MedComms and patient-engagement agency who help our clients create and share engaging content. Our innovative...

Latest intelligence

OUTiCO Case Study - Product Launch
POSITIVE FORMULARY SUCCESS WITHIN 8 MONTHS!...
An insight into Multi-Channel Account Management
At OUTiCO we often talk about moving away from traditional methods, embracing change, and offering an exceptional outsourcing service, but what does that mean day to day?...
14_ipad_lowres.jpg
Why AI might be the rep’s best friend
When looking for the next big thing in digital communication, there’s nothing bigger than the sweeping changes promised by artificial intelligence. There’s little doubt that AI is coming to pharma...

Infographics