Eli Lilly reported Tuesday top-line results showing that its experimental diabetes drug dulaglutide was non-inferior to Novo Nordisk's Victoza (liraglutide) as measured by the reduction of haemoglobin A1c from baseline at 26 weeks, meeting the study's main goal. Enrique Conterno, president of Lilly Diabetes, remarked that dulaglutide "is the only GLP-1 agonist to show non-inferiority against [Victoza's] highest-approved dose in a Phase III trial."
The AWARD-6 study randomised 599 patients with type 2 diabetes on concomitant metformin to receive once-weekly dulaglutide at a dose of 1.5 milligrams or once-daily Victoza at a dose of 1.8 milligrams. Eli Lilly noted that adverse events were similar for patients in both treatment groups, while the most frequently reported side effects were gastrointestinal-related. The company indicated that it will present detailed results from the trial at scientific meetings later this year.
Sherry Martin, a senior medical director at Eli Lilly, noted that dulaglutide wasn't superior to Victoza in average HbA1c reduction in the study, although she added that "options that allow patients to more easily use the treatment are, we believe, important." Sanford C. Bernstein & Co. analyst Timothy Anderson said that the non-inferiority result meets investor expectations. "Dulaglutide should be well-positioned in the marketplace by virtue of attributes like its once-weekly dosing and its small needle size," Anderson added, comparing it to Victoza’s daily dosing and the larger needle of AstraZeneca's Bydureon (exenatide).
Eli Lilly submitted marketing applications for dulaglutide to the FDA and European Medicines Agency in 2013, with a decision from US regulators expected by September. Conterno said that "if approved, dulaglutide would be the only GLP-1 agonist that is both once-weekly and ready-to-use." Analysts predict that the drug could generate sales of $853 million in 2019, with ISI Group estimating peak annual revenue of about $2 billion.
Novo Nordisk spokesman Ken Inchausti said "we look forward to reviewing the full data set from this study before assessing its meaning any further." Victoza generated sales of about $2.1 billion last year.
For more information on the diabetes market, see FirstWord Lists – Diabetes launches to continue unabated: what is in the late-stage pipeline? and Diabetes -- KOL Insight and Consensus Outlook Modules.
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