Boehringer Ingelheim and its recently signed-up partner Eli Lilly are celebrating the news that regulators in the USA have given the green light to their once-daily type 2 diabetes pill linagliptin.

The US Food and Drug Administration has approved linagliptin, which will be sold as Tradjenta, to improve blood glucose control in adults with type 2 diabetes, in tandem with diet and exercise. The thumbs-up is based on data from eight clinical studies involving about 3,800 patients with Type 2 diabetes and Tradjenta has been studied as a stand-alone therapy and in combination with other type 2 diabetes therapies including metformin, glimepiride and pioglitazone.

Tradjenta will be dispensed with an FDA-approved patient package insert that explains its risks. The most common side effects seen in studies were upper respiratory infection, stuffy or runny nose, sore throat, muscle pain and headache.

The drug increases the level of hormones that stimulate the release of insulin after a meal by blocking the enzyme dipeptidyl peptidase-4, which leads to better blood glucose control. However linagliptin will face a major battle in making up ground in the USA on Merck & Co's well-established DPP-4 inhibitor Januvia (sitagliptin) and Janumet (sitagliptin and metformin), which are both selling extremely well (see today's Merck story).

Boehringer linked up with Lilly in January and at the time some analysts believed the US firm had got the best deal, as it faces up to upcoming patent losses on the antipsychotic Zyprexa (olanzapine) and the antidepressant/fibromyalgia blockbuster Cymbalta (duloxetine).

Lilly ideal partner

A number of companies were looking at negotiating rights to linagliptin but Englebert Tjeenk Willink, head of pharmaceutical sales and marketing, told PharmaTimes World News at the German firm's recent annual press conference that linking up with Lilly was the right choice as Boehringer was not interested in just a co-promotion.

He mentioned Lilly's "huge experience base" in diabetes and noted that a partnership made sense in terms of risk mitigation and hard cash. However, Dr Tjeenk Willink added that the most important part of the deal was the pipeline Lilly brings to the alliance, namely two basal insulin analogue candidates, which are going into Phase III.