NEW ORLEANS--Diabetes researchers, endocrinologists and primary care docs, patient advocacy groups and, of course, media descended on this city over the weekend to catch the latest data on the disease. Though some of the most-anticipated results--cardiovascular outcomes data on Novo Nordisk’s Victoza, for instance--won’t be presented till later Monday and Tuesday, FiercePharma found plenty of news on drugs worth watching. Here’s our selection.
Merck & Co. and Pfizer are doubling down on their ertugliflozin cardiovascular outcomes study as rival SGLT-2 med Jardiance continues to generate buzz for its score in a heart-safety test. The development partners are now looking to enroll 8,000 patients, to power the study to gauge ertugliflozin’s benefits in addition to risks. They also added two secondary endpoints--cardiovascular death, and a composite endpoint covering CV death and hospitalization for heart failure. Article
Novo Nordisk has staked out a big portion of its pipeline for semaglutide, the once-weekly GLP-1 drug that could follow in the footsteps of its blockbuster daily, Victoza. And this weekend, it fleshed out two studies that pitted the drug against two future competitors. Semaglutide topped AstraZeneca’s weekly GLP-1, Bydureon, and Merck & Co.’s Januvia, a DPP-4 med and fellow incretin mimetic, showing “very consistent and excellent improvements” over those meds, CMO Todd Hobbs said in an interview. Report
Sanofi’s LixiLan is already at the FDA--it even has advisory committee backing for approval. But the data keeps coming on the French drugmaker’s combo, which pairs its best-selling basal insulin, Lantus, with a new GLP-1 drug Lyxumia (lixisenatide). The med hit its goals in two pivotal trials presented here, beating both its parts in type 2 diabetes. Story
Eli Lilly’s GLP-1 drug Trulicity hasn’t been resting on its weekly dosing advantage, but racking up new data in a variety of patient groups to build a broader case. The AWARD-9 trial presented Sunday tested Trulicity alongside Sanofi’s Lantus (insulin glargine), and the combo beat Lantus alone at every measure. News
In diabetes trials, Johnson & Johnson’s Invokana has helped some patients lose weight--sometimes more weight than they did on another diabetes treatment. Could the drug work for weight loss in patients without diabetes? The answer was yes in a proof-of concept trial presented Saturday, which showed that combining Invokana (canagliflozin) with the older weight-loss med phentermine delivered a 7.5% loss of body weight. Report
Novo Nordisk’s next-gen basal insulin Tresiba has a tough task: To steal market share from the long-dominant Sanofi product Lantus, at a time when Sanofi has its own follow-on product Toujeo in the mix. Novo thinks it has a tag line, though. In two late-stage studies, Tresiba patients suffered fewer episodes of hypoglycemia--a feared risk of insulin treatment--compared with Sanofi’s blockbuster. Article
Sanofi’s Toujeo earned good marks in a real-word study of patients who switched to the new long-acting product from another basal insulin. Type 2 diabetes patients in the study successfully switched to Toujeo, with improvements to their A1C numbers and hypoglycemia risks. Release
Takeda already knew from 2013 results of a cardiovascular outcomes trial that its Type 2 diabetes med, Nesina, didn’t increase the risk of CV events for ACS patients when compared with placebo. But now it knows the same is true of the risk of death. Story
AstraZeneca is trumpeting positive data from a pair of analyses on SGLT2 contender Farxiga. In one, researchers found that Farxiga recorded a decrease in body weight and blood pressure among patients with kidney problems that was similar to the decreases it posted among those with mild renal impairment or normal kidney function. And in the other, Farxiga--when administered alongside a potassium-sparing diuretic--cut down A1C, body weight and blood pressure without significantly upping potassium levels, researchers found, eliminating the potential for the hyperkalemia concerns that have surround Johnson & Johnson rival Invokana. Story