SAN DIEGO—Fresh off the surge of cancer data at the American Society of Clinical Oncology meeting last week, FiercePharma is surfing the annual wave of news in diabetes.
At the American Diabetes Association Scientific Sessions in San Diego, drugmakers have been rolling out studies that illustrate how competitive every class in the diabetes field has become. For instance, partners Merck & Co. and Pfizer, Eli Lilly and Boehringer Ingelheim, and solo flyer AstraZeneca all unveiled SGLT2 drug studies, with more to come.
Another takeaway from the lineup of studies? Just how intertwined the data on diabetes meds and cardiovascular (CV) treatments have become. Case in point: The meeting’s most closely watched study—Johnson & Johnson’s Invokana CV outcomes trial—is slated for presentation Monday afternoon. (It’s an SGLT2 drug, too, by the way.)
Meanwhile, Novo put up new analyses from its Leader CV outcomes study on the GLP-1 drug Victoza, which scored risk-cutting data of its own. Eli Lilly and Boehringer Ingelheim rolled out analyses of their Empa-Reg Outcome study, in which their own SGLT2 med Jardiance became the first diabetes med to cut the risk of cardiovascular problems, including death, in diabetics. And Sanofi and Regeneron posted two new trials of their PCSK9 drug Praluent and its ability to safely slash cholesterol levels in diabetes patients.
It’s a lot to track, so we’ve gathered the top stories here. Check back as the week progresses for updates.
Johnson & Johnson's Invokana outcomes study makes it the second heart-helping SGLT2 on the block. But compared with results from Eli Lilly and Boehringer Ingelheim's Jardiance outcomes trial, the J&J data shows that the match-up in overall CV risk reduction—at 14%—comes with a big increase in amputations. And while the J&J med delivered individual decreases in risk of heart attack and stroke, its reduction in risk of cardiac death fell short of Jardiance's 38%.
Novo Nordisk and its long-acting insulin Tresiba have a tough task: going up against Sanofi's blockbuster insulin Lantus. Thanks to new data, though, the Danish drugmaker can safely say its newcomer poses no increased heart risks—and it has some advantages over its rival, too. Novo unveiled a 7,637-patient study displaying its cardiovascular safety while highlighting a decreased rate of severe hypoglycemia, including a 53% cut in overnight episodes.
Lilly and Boehringer have reason to believe their SGLT2 inhibitor, Jardiance, may improve outcomes for chronic kidney disease patients—so they’re putting the med to the test. On Monday, in the middle of the American Diabetes Association’s annual meeting, the pair announced plans to run a new outcomes trial specifically aimed at assessing Jardiance in kidney disease patients, both with and without diabetes.
Sanofi’s Toujeo has plenty of competition in the basal insulin market, but new real-world data shows it may outdo its peers at cutting the risk of hypoglycemia for older patients. Among at-risk seniors who’d switched to basal insulin, those taking Toujeo were 57% less likely to experience hypoglycemia than those who switched to competing insulins—such as Novo Nordisk’s Tresiba and Levemir, and Toujeo’s own predecessor, Lantus. And Sanofi's planning three real-world follow-ups, a "major shift" from its usual data approach.
Sanofi and Regeneron still have months to wait for final data from a key cardiovascular outcomes study of their PCSK9 therapy Praluent, which is in a heated battle with Amgen’s Repatha. But Praluent now has results suggesting it can safely cut "bad" cholesterol in Type 2 diabetes patients at high risk of CV problems. Eighty percent of Praluent patients reached their recommended target LDL cholesterol goal, and researchers declared it safe for Praluent and insulin to be taken together.
Novo Nordisk is in a tough market race against Sanofi with combo product Xultophy, which hit the market after the French drugmaker’s similar Soliqua. New basal-bolus topping data, though, could give the medication a leg up. Switching to Xultophy—which marries Novo's newest basal insulin, Tresiba, with its top-selling GLP-1 med Victoza—didn’t come along with the increases in hypoglycemia and weight that are usually “one of the tradeoffs” for basal insulin patients who need to add mealtime insulin to their therapy, a Novo CMO said.
Boehringer and Lilly still don’t know what’s responsible for the dramatic reduction in cardiovascular death risk that Jardiance (empagliflozin) posted in the Empa-Reg outcomes trial. But they know what isn’t: blood pressure, LDL cholesterol and HbA1c, a key measure of blood glucose. Managing all those metrics “will not give the same effect that you see with Empa-Reg,” a BI exec said in an interview. Researchers will keep looking for the Jardiance key, he said.
Merck and Pfizer last year rolled out positive results from two phase 3 studies they hoped would buoy SGLT2 candidate ertugliflozin once it got to market. This year, they’re doing it again. Saturday, the pair announced their candidate had significantly cut down levels of A1C—a key measure of blood glucose—when taken alongside their Merck DPP-4 giant Januvia (sitagliptin) and when added to metformin.
And in case you missed our diabetes drug special report, rolled out last week as the meeting began, take a look at the top 10 diabetes drugs in the U.S., ranked by 2016 sales.