Novo Nordisk's Semaglutide Bests Trulicity in Diabetes Trial

Longer-acting GLP-1 diabetes drug reports strong results in Sustain-7 trial

Semaglutide, a longer-acting version of liraglutide (Victoza, Novo Nordisk), delivered better reductions in blood sugar and double the weight loss in a head-to-head comparison with dulaglutide (Trulicity, Eli Lilly), FiercePharma reports.

Novo Nordisk has been counting on semaglutide to help replace daily-dosed Victoza as Trulicity and other longer-acting GLP-1 drugs angle for a share of that growing market. The data comes at a time when pricing pressure in diabetes is at an all-time high, particularly in the basal insulin field, and other classes may offer greater potential for payer support, FiercePharma notes.

“The efficacy/weight data was exactly as they said it would be—Strong!” wrote Bernstein analyst Ronny Gal in an investor note, adding that the trial data confirms his estimate that GLP-1 drugs will grow, volume-wise, to 7% of the overall diabetes market from 4% now.

In fact, Evercore ISI analyst Umer Raffat deemed the Sustain-7 trial results as a “best-case outcome for Novo,” not only for the performance on the efficacy side, but for its side effects numbers. An imbalance in retinopathy cases cropped up in a previous semaglutide trial, but in comparison with Trulicity, the retinopathy cases were “low and comparable” in both arms of the study, Raffat noted.

The blood glucose and weight loss advantages join another differentiating factor for semaglutide: Proven cardiovascular (CV) benefits, FiercePharma says. The drug maker is running a larger outcomes trial to confirm the size of that benefit, but Trulicity has yet to post CV risk-reduction data, and those benefits don’t appear to apply to the entire class; two other medications in the field, AstraZeneca’s Bydureon and Sanofi’s Lyxumia, failed to deliver CV benefits in their own outcomes trials, although they did prove safe for the heart.

“Novo will now be in a strong position when discussing semaglutide with payers, having demonstrated superiority versus the competition and also the added CV benefit, which Lilly has yet to do,” Gal noted. His firm sees semaglutide as the GLP market leader by 2025.

That strength with payers will be important as diabetes medications face ever-more pressure to deal on price in return for favorable formulary placement. Indeed, Novo CEO said in an interview last week that payers already understand that drugs in the GLP-1 class are more distinct than basal insulins. Even price cuts haven’t necessarily worked.

“The launch of [GLP-1] products relies a lot on efficacy if you look at the ability to lower glucose level, and also the weight profile, so they are more differentiated, and those products that have not had the best clinical profile have played more with price,” Lars Fruergaard Jorgensen told FiercePharma, adding that GlaxoSmithKline’s decision to pull its entry in that market, Tanzeum, is evidence of that differentiability.

In Sustain-7, semaglutide cut the standard measure of blood sugar levels, HbA1C, by 1.5% at a lower dose, compared with Trulicity’s 1.1%; the higher doses compared at 1.8% and 1.4% respectively. The trial tested both drugs alongside metformin. On weight loss, the difference was even bigger. People treated with the lower semaglutide dose lost a median 4.6 kg, while those on the higher dose lost 6.5 kg at the median. Patients on Trulicity, on the other hand, lost 2.3 kg at the lower dose and 3.0 kg on the higher dose.

As for the cardio-risk data, that trial pitted semaglutide against placebo. In the Sustain-6 study, presented last September, the drug cut the risk of cardiovascular problems by 26%. Semaglutide cut stroke risks by 39% and heart attack by 26%, though the latter was statistically nonsignificant. The follow-up trial—a much larger one—should shed more light on those benefits, R&D chief Mads Krogsgaard Thomsen said at the time.

Source: FiercePharma; August 17, 2017.