Dive Brief:
- AstraZeneca announced Monday morning it will begin two new large Phase 3b cardiovascular outcomes trials for its type 2 diabetes drug Farxiga (dapagliflozin).
- The trials will test the potential of the sodium glucose co-transporter (SGLT)-2 inhibitor to provide cardiovascular and renal benefit for patients with and without diabetes.
- The late-stage studies will take place in patients with chronic kidney disease and chronic heart failure.
Dive Insight:
Trying to compete in the crowded diabetes space, AstraZeneca is hoping that results from two cardiovascular outcomes trials will differentiate its late-to-market SGLT-2 inhibitor.
Farxiga was approved by the U.S. Food and Drug Administration in January 2014 — almost a year after Johnson & Johnson's first-to-market SGLT-2 inhibitor Invokana (canagliflozin) got a greenlight. It did, however, beat Eli Lilly & Co and Boehringer Ingelheim's Jardiance (empagliflozin) by more than eight months.
SGLT-2 drugs —a new class of diabetes drugs that causes excess sugar to be evacuated via the urine — has been growing at a faster clip than analysts initially anticipated when Invokana was first launched. Even so, Farxiga has failed to find a niche.
While Invokana has the first-to-market advantage, Jardiance gained ground by showing it has cardio-protective properties in a large cardiovascular outcomes trial dubbed EMPA-REG.
More recently, Lilly and Boehringer released further data from EMPA-REG showing Jardiance helps in slowing the progression of chronic kidney disease in patients with type 2 diabetes.
Unfortunately for AstraZeneca, cardiovascular outcomes trials include a large number of patients and often take years to complete — making the competitive edge it seeks could be far down the road.