AstraZeneca PLC announced results from a five-year study of its diabetes drug Farxiga in patients with the type 2 version of the disease, demonstrating that the treatment significantly reduced the risk of hospitalization for heart failure.
Farxiga is a sodium-glucose cotransporter-2, or SGLT2, inhibitor — a class of medicines which lower blood sugar levels by making the kidneys remove it through urine. The U.K.-based company announced the trial results at the American Heart Association Scientific Sessions in Chicago on Nov. 10.
The study, called DECLARE, enrolled more than 17,000 patients across 33 countries. In the trial, Farxiga demonstrated a 17% reduction in the risk of hospitalization for heart failure or cardiovascular death as compared to placebo.
"That in itself is a very important new element and hasn't been shown before," Ruud Dobber, AstraZeneca's U.S. president, told S&P Global Market Intelligence.
"Out of the 30 million diabetic patients in the United States, roughly 50% will get heart failure and 50% of that population will die within five years," he said.
Because there is a significant overlap of patients with both diabetes and heart-related conditions, drugmakers are looking to their established diabetes medicines for indications that can also help prevent cardiovascular risk.
SGLT2 drugs can come with a host of side effects, including risk of infection, bladder cancer and amputation, but Farxiga scored well against placebo on those counts.
"There were question marks about potential bladder cancer, about Fournier's gangrene, bone fractures and stroke," Dobber said. "In fact, all those side effects in the clinical trial are less than in placebo. So it has just a very compelling safety profile."
Side effects
Dobber said that one potential side effect, diabetic ketoacidosis, is in line with other drugs in the class.
The reason for the cardiovascular effect is not quite understood but is thought to be a combination of factors that leads to the benefits.
"We don't know exactly how it works, and we think it's partly from decreasing the blood sugar, but it's beyond just the glycemic control where you see the benefits it actually provides," Naeem Khan, AstraZeneca's vice president of cardiovascular and metabolic disease, told S&P Global Market Intelligence.
"It's a number of vascular as well as renal effects that we think leads to a cardiovascular effect overall," Khan said.
Based on the DECLARE study, AstraZeneca hopes to file with the U.S. Food and Drug Administration for the heart failure indication in the first half of 2019, Dobber said.
Among AstraZeneca's competitors in the SGLT2 class are Jardiance from Boehringer Ingelheim GmbH and Eli Lilly and Co. and Invokana from Johnson & Johnson. In 2016, Jardiance garnered a U.S. FDA indication to lower the risk of cardiovascular death in type 2 diabetes patients based on a placebo study.
Farxiga is currently undergoing a cardiovascular study in patients without diabetes, Dobber said, the results of which AstraZeneca will announce in 2020 or 2021.