Lilly's dulaglutide claims the edge over Victoza in AWARD 6
This article was originally published in Scrip
Eli Lilly's investigational antidiabetic dulaglutide looks set to make its presence felt in the GLP-1 agonist space on the basis of Phase III head-to-head data showing a strong performance against current market leader, Novo Nordisk's Victoza (liraglutide).
Results presented this weekend at the American Diabetes Association meeting in San Francisco show a similar therapeutic performance for the new GLP-1 agonist contender compared with liraglutide, with the added bonus of once-weekly, rather than daily, dosing.
Although, if approved, dulaglutide will be the third once-weekly GLP1 agonist product to market, following AstraZeneca's Byetta (exenetide once weekly) and GlaxoSmithKline's Tanzeum (albiglutide), its small-gauge injection pen device and its HbA1c profile, coupled with Lilly's long experience in the diabetes market, should hold it in good stead. Analysts at Datamonitor Healthcare expect it to become the best-selling GLP-1 agonist product by 2022 across the US, Japan, and the five major EU markets (France, Germany, Italy, Spain and the UK).
Dulaglutide is awaiting US and EU approval following filings last autumn, and the company is hopeful of approvals by the end of the year.
At the ADA meeting, Lilly presented the full results of the AWARD 6 study, top-line results from which were released in February (scripintelligence.com, 25 February 2014). Data from the AWARD studies 1 to 5 in the Phase III program were included in the regulatory dossiers, while the companies hope the AWARD 6 data will form an important part in differentiating dulaglutide from its competitors.
The non-inferiority AWARD 6 study in 599 type 2 diabetes compared 1.5mg of dulaglutide once a week, to 1.8mg of liraglutide daily in addition to pre-study prescribed metformin demonstrated similar reductions in average blood sugar levels (HbA1c), across both arms (-1.42% and -1.36%, respectively) at 26 weeks (the primary endpoint).
A similar proportion of patients in both groups (68%) reached the American Diabetes Association's recommended HbA1c target of less than 7%. Patients treated with once-weekly dulaglutide and once-daily liraglutide showed significant weight reductions from baseline (-2.9 kg, -3.6 kg, respectively), but here the weight reduction was statistically greater in the liraglutide 1.8mg treatment arm.
For nausea, a common adverse event with this class, there was no significant difference between the two treatments, Dr Jessie Fahrbach, AWARD medical director, told Scrip. The rates were 20.4% with dulaglutide and 18.0% with liraglutide. "What we see with dulaglutide is very consistent with the class. In this study, the adverse events were almost identical in terms of numbers of patients with GI effects including nausea and the pattern of nausea over time," she said, noting that patients had an average of 26 injections of dulaglutide over the 26 weeks of the study compared with 182 injections of liraglutide.
Dr Sherry Martin, senior medical director at Lilly Diabetes, said, "The package of benefits [with dulaglutide] involves a group of attributes we feel is required for it to be the important new treatment option, if approved … Looking at dulaglutide's profile we feel – especially in the once-weekly space – that we have attributes that will make it a very competitive choice for physicians looking across the safety and efficacy profiles [of these drugs]." These attributes include the easy to use preparation which just requires patients to press a single button, she added. "Particularly for patients who are first moving to injections, often a space for the GLP1s, a very user-friendly first injection experience is important in this class."
Analysts at Credit Suisse say the dulaglutide launch expected later this year "could be an important catalyst for GLP-1 market growth". "Despite slightly less weight loss profile relative to Victoza, we think dulaglutide can still be a competitive product amid once-weekly administration and ready-to-use solution formulation," they said.