Eli Lilly has put the flesh on the bones of its REWIND cardiovascular outcomes study for diabetes drug Trulicity, a key element in its defence against a rival drug from Novo Nordisk.
Lilly revealed last November that the top-line data with the once-weekly GLP-1 agonist was positive, and over the weekend at the American Diabetes Association meeting, presented the detailed data from the trial, which has also been published in The Lancet.
All told, there was a 12% reduction in major adverse cardiovascular events (MACE) in middle-aged and older people with type 2 diabetes – including cardiovascular death, non-fatal myocardial infarction or non-fatal stroke – as well as a 15% drop in the development of kidney disease compared to placebo over more than five years of follow-up.
Lilly says the results are significant because they are among the first to show that a type 2 diabetes drug can show a benefit on MACE in patients both with and without established cardiovascular disease, a population “more representative of people with type 2 diabetes typically seen in clinical practice.”
The big question is whether the size of the improvements is enough to fend off a challenge to Trulicity from Novo Nordisk’s once-weekly GLP-1 agonist Ozempic (semaglutide), which was launched last year.
Ozempic has been growing quickly since launch and brought in DKK 1.4bn ($211m) in the first quarter of this year. It still has along way to go to catch Trulicity, which brought in $880m in the same period, but Novo Nordisk says its market share in the US is now 30% and it is claiming around 50% of new-to-brand prescriptions.
Trulicity’s growth to date has stemmed largely from its once-weekly dosing, which proved a popular alternative to daily GLP-1 agonists such as Novo Nordisk’s older drug Victoza (liraglutide). Now, the competition in the market is considerably more intense.
With all the caveats about comparing trials with different designs, Novo Nordisk will be able to point to its cardiovascular outcomes study – SUSTAIN-6 – which found a 26% lower risk of MACE compared to placebo over a period of two years. It is already trumpeting data showing Ozempic seems to be superior to Trulicity in maintaining glucose control when added to background treatment with metformin.
Lilly points out that Ozempic’s data comes from a population mainly with established cardiovascular disease, rather than a ‘real-world’ spectrum of patients, and includes a much longer follow-up period. More than 46% of participants were women, and less than a third had previous cardiovascular disease.
The REWIND results have been submitted to regulatory authorities in the US and Europe for review, it says.
Meanwhile, Novo Nordisk presented new data at ADA on its next challenger for a slice of the GLP-1 agonist market, an oral formulation of semaglutide that is currently in a fast-track review by the FDA with a verdict due in September.
Results from phase 3 trials of the drug presented at the ADA found that it was better at maintaining glucose control than Lilly and Boehringer Ingelheim’s oral SGLT2 inhibitor Jardiance (empagliflozin) equivalent to once-daily injectable Victoza at both six- and 12-month timepoints.
Novo Nordisk has data in hand for a cardiovascular risk reduction claim for oral semaglutide, and has also filed this with the FDA under a standard review which should be completed early next year.