In the last six months, Eli Lilly has announced that its GLP-1 analogue, dulaglutide, has met its primary end point in a series of trials comparing its safety and efficacy with current diabetes agents. As potentially the fifth GLP-1 analogue to market in the United States and Europe, dulaglutide will be entering a competitive environment where it is more important than ever for new market entrants to differentiate themselves from existing agents.
The high prevalence of type 2 diabetes, and the large market opportunity associated with this disorder has historically ensured that every novel agent (including those that did not significantly differentiate themselves from marketed agents) could capture significant sales. However, following the global financial crisis, payers, particularly in the European Union, are increasingly scrutinizing clinical trial data for newer diabetes drugs, and questioning whether the premium prices assigned to these agents are justified. Furthermore, companies must jump through an increasing number of regulatory hoops to win approval and demonstrate the ability of any new diabetes drug to be used with a multitude of other classes, as is the case in clinical practice where polypharmacy is a common occurrence.
For these reasons, Eli Lily embarked on a comprehensive series of trials comparing dulaglutide's ability to lower HbA1c compared with a wide range of existing diabetes drugs--The AWARD clinical trial program (see Table 1).