AstraZeneca searches for differentiator in diabetes market
- 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.
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.
- AstraZeneca Press Release
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