Novo's semaglutide beats Lilly's Trulicity in diabetes contest

Novo Nordisk says its once-weekly GLP-1 agonist semaglutide could become a "new standard" in type 2 diabetes after beating rival Eli Lilly's Trulicity (dulaglutide) in a phase III trial.

The data could throw a spanner into Lilly's plans for Trulicity, a key growth driver for the company which saw sales leap 147% in the first six months of 2017 to $853m, taking it firmly into blockbuster territory. Trulicity's growth stems from its once-weekly dosing, which has proved a popular alternative to daily GLP-1 agonists such as Novo's Victoza (liraglutide).

The results of the SUSTAIN 7 trial found that patients treated with semaglutide achieved a greater reduction in haemoglobin A1c levels - a measure of sustained glucose control - compared to Lilly's drug when added to metformin treatment.

Patients had a mean baseline HbA1c level of 8.2% at enrolment. After 40 weeks, a 0.5g dose of semaglutide cut levels by 1.5%, compared to 1.1% with 0.75mg dulaglutide. A similar pattern was seen in a higher dose group, with 1.0mg semaglutide cutting HbA1c by 1.8% and a 1.5mg dose of Lilly's drug reducing it by 1.4%.

Both differences were statistically significant according to Novo, which also said that semaglutide helped patients lose more weight than those on dulaglutide. The drug also proved more effective supporting patients’ HbA1c treatment targets than its rival.

That's important as it could give Novo another differentiator for semaglutide versus Trulicity, and help the company promote the drug for overweight diabetics, while giving it another positive benefit to help overcome payer resistance in the diabetes category.

The data is also a boost because the company has ambitions to position semaglutide as a weight-loss drug, having reported positive phase II data in June that it said suggested the drug could "set a new efficacy standard for anti-obesity medicines". A phase III programme is due to get underway in obesity next year.

Also critically for Novo its drug showed a similar rate of diabetic retinopathy to that seen in Trulicity trials, which could quell concerns about that side effect raised in earlier studies. The number of people reporting an adverse event of diabetic retinopathy was low and comparable in both the semaglutide and dulaglutide groups - at four and five events, respectively - according to Novo.

Novo has filed marketing applications for semaglutide in the US, EU and Japan and could start to claim approvals before the end of the year. It also has an oral formulation of the drug in development that could expand the franchise.

EvaluatePharma predicted in its recently-published World Preview 2017 document that cumulative sales of semaglutide in the next five years could be as much as $8.7bn, putting it in the top 10 among pipeline products currently heading for market. It predicts sales of $2.2bn in 2022.