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Lilly trumpets Trulicity heart data in face-off with Novo Nordisk

Shows benefits in patients without established CV disease

Trulicity

Eli Lilly has cardiovascular outcome data for its diabetes drug Trulicity that could help it fend off a challenge from Novo Nordisk’s Ozempic.

The results of the REWIND study showed that Trulicity (dulaglutide), a once-weekly GLP-1 agonist, significantly reduced major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal myocardial infarction or non-fatal stroke in type 2 diabetics compared to placebo when given on top of standard care.

The results – which will be presented in full at a future medical conference – make Trulicity the first type 2 diabetes drug to show a benefit on MACE in patients without established cardiovascular disease, says Lilly, as less than a third (31%) of patients had established heart disease at enrolment.

Novo Nordisk launched its weekly GLP-1 agonist rival Ozempic (semaglutide) in the US earlier this year, and says it is growing fast with sales of DKK 804m ($122m) in the first nine months of the year, helped by data suggesting it is superior to Trulicity in maintaining glucose control when added to background treatment with metformin. It still has a long way to go to catch Trulicity, however, which made $1.5bn in the first half.

Trulicity is expected to be a big driver for Lilly once again, when the company reports its third-quarter results later today, stealing market share from Novo Nordisk’s once-daily GLP-1 drug Victoza (liraglutide), and if it can get a cardiovascular outcomes claim on its label it will shore up the product’s competitive profile.

Boehringer Ingelheim and Lilly’s SGLT2 inhibitor Jardiance (empagliflozin) was the first drug approved by the FDA as being able to reduce the risk of cardiovascular death in patients with type 2 diabetes with established cardiovascular disease based on data from the EMPA-REG trial, and all the big diabetes players have been racing to generate this type of data for their products.

The LEADER trial of Victoza also showed a 13% MACE risk reduction, for example, although Johnson & Johnson was less fortunate with its CANVAS trial of SGLT2 inhibitor Invokana (canagliflozin), as a reduction in cardiovascular risk was accompanied by an increased in lower limb amputation. The near-term question for Lilly now is whether Trulicity matches Victoza’s efficacy.

Novo Nordisk already has positive results for Ozempic from the SUSTAIN 6 trial which generated results in 2016, but that wasn’t enough to get a cardiovascular protection indication on approval because it was only statistically powered to show non-inferiority to placebo.

The company has discussed a larger outcomes trial for Ozempic, but seems to have taken a different tack for now, testing the drug in overweight and obese patients with heart disease in the SELECT trial and excluding patients with diabetes or elevated glucose levels.

Meanwhile Boehringer and Lilly also have new real-world data for Jardiance from a patient registry, showing that the drug was able to reduce the risk of hospitalisation for heart failure by 44% compared to DPP4 inhibitors, another widely used class of drug for type 2 diabetes.

The EMPRISE analysis is from records involving approximately 35,000 people with type 2 diabetes between August 2014 and September 2016 and according to Boehringer, show that the benefits of Jardiance seen in the EMPA-REG trial translate into routine clinical care.

6th November 2018

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