FDA Shoots Down AstraZeneca Diabetes Compound Drug on the Heels of Cancer Combo

Susanna Sisson's picture
AstraZeneca Diabetes Drug Declined by FDA

When the Food and Drug Administration says “NO” to a drug maker, there has to be a very good reason. On October 9, London based AstraZeneca announced it would halt two clinical trials on a combination cancer drug used to treat lung cancer due to evidence of increased lung disease.


That news was followed on October 16 by an announcement that the FDA had not given approval to move forward with a new combination diabetes drug containing saxagliptin and dapagliflozin, two currently approved diabetes drugs. It appears the FDA is going to require more clinical data and possibly new clinical trials, a very costly and time consuming process for pharmaceutical companies as is potential loss of revenue from the sale of the drug.

“AstraZeneca’s therapy could potentially generate at least $850 million in sales by 2020,” estimated Fabian Wenner, an analyst at Kepler Cheuvreux. Bloomberg Business analyst Sam Fazeli, commented that “The combination would have competed with Glyxambi from Lilly, a drug that now has “a clear run in the U.S.”” [1]

But with known serious side effects one has to ask just why were the competitor’s drugs ever approved? Dare we ask?

Saxagliptin marketed as Onglyza was approved for use by the FDA in 2009. The drug is an orally-active inhibitor of the Dipeptidyl peptidase-4 (DPP4) enzyme. D-PP4 inhibitors work by affecting the action of natural hormones in the body called incretins.


There is a long list of potential side effects including respiratory and urinary tract infections (UTI), pancreatitis, high blood pressure, anemia, disabling joint pain, depression, headache, fatigue and many others. [5]

Some doctors are concerned by reports of a possible increased risk of pancreatitis (inflammation of the pancreas) and pancreatic and thyroid cancer associated with incretin-based therapies like Onglyza. Hundreds who took these drugs filed lawsuits against the drugs’ makers after they developed pancreatitis or pancreatic cancer, claiming that the drug companies failed to warn of the risk. [4]
According to the New England Journal of Medicine [2], the American Heart Association [4], and identified by the FDA in February 2014, another potentially fatal side effect of Onglyza is heart failure. [7] This increase in risk was noted to be highest among patients with elevated levels of natriuretic peptides, prior heart failure, or chronic kidney disease.

Dapagliflozin marketed by AstraZeneca under the name Forxiga inhibits subtype 2 of the sodium-glucose transport proteins (SGLT2) which are responsible for at least 90% of the glucose reabsorption in the kidney. The drug was approved in January 2014 and has already had bad press and has been called the worst new drug of 2014. [9]

The FDA requires a warning for bladder cancer patients that they shouldn’t take Farxiga because it might make their cancer worse. In addiction they are requiring the company to study 17,000 diabetes patients for at least four years to determine whether and how often patients taking Farxiga are diagnosed with cancer, liver problems, or heart disease when the drug is taken for a longer period of time.
Side effects include hair loss, dehydration which can lead to kidney failure, mild to moderate kidney damage, genital fungal and urinary infection, general infections, influenza, increased ketoacidosis, hepatitis, liver failure, back pain, bone fractures, breast and bladder cancer and heart failure. There are other side effects but isn’t the risk of these enough to say a definitive “no”? [8]

While the drugs do lower blood sugar the serious health risks of both drugs much less a combination of the two should raise eyebrows and concerns over any possible benefits especially with potential use by as many as 382 million people globally who have diabetes. As with any health problem prevention and non-chemical methods to control the disease are preferable over any drug therapy.

1. http://www.bloomberg.com/news/articles/2015-10-16/astrazeneca-fails-to-win-fda-backing-for-combined-diabetes-drug
2. http://www.nejm.org/doi/full/10.1056/NEJMoa1307684
3. http://circ.ahajournals.org/content/early/2014/09/04/CIRCULATIONAHA.114.010389
4. http://www.drugwatch.com/onglyza/
5. http://www.drugs.com/sfx/saxagliptin-side-effects.html
6. https://www.centerwatch.com/drug-information/fda-approved-drugs/drug/1042/onglyza-saxagliptin
7. http://www.fda.gov/Drugs/DrugSafety/ucm385287.htm
8. http://www.drugs.com/sfx/dapagliflozin-side-effects.html
9. http://www.huffingtonpost.com/maria-rodale/the-worst-new-drug-of-201_b_4723514.html



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