AstraZeneca, the global biopharmaceutical company that manufacturers the anti-cholesterol statin drug Crestor, which is known to cause type 2 diabetes within two weeks of taking it, even at modest dosages, is marketing a new drug to treat the disease.
US health regulators have now approved the new AstraZeneca drug Farxiga after previously rejecting it over safety concerns.
The new drug was co-developed by Bristol-Myers Squibb and AstraZeneca. AstraZeneca late last year bought out Bristol’s stake in its diabetes joint venture for more than $4 billion.
Farxiga, which has already been available in Europe, belongs to a class of diabetes drugs called SGLT-2 inhibitors that work by blocking reabsorption of glucose by the kidney and increasing its excretion through urine to lower levels of blood sugar.
It will compete with a similar drug from Johnson & Johnson called Invokana, as well as diabetes medicines from other classes.
The FDA had initially rejected the Astra and Bristol-Myers drug in early 2012 over concerns about possible cancer and heart risks. The companies provided additional data that addressed those concerns to the satisfaction of the advisory panel and the agency.
Still, as a condition of approval, the FDA is requiring six post-marketing studies, including a cardiovascular outcomes trial to make sure the medicine does not increase the risk of heart attacks in patients deemed at high risk of heart disease, and a study to assess bladder cancer risk. The FDA-approved label for Farxiga says the drug should not be used in patients who also have kidney disease or who are being treated for bladder cancer.
The innovation is the latest in AstraZeneca’s efforts to invest heavily in emerging treatments for diabetes – a disease that represents a $465 billion market. A growing epidemic, diabetes is projected to affect 550 million people worldwide by 2030.
AstraZeneca is therefore in the happy position – for it, although not for those affected – of earning billions from a drug that causes type 2 diabetes and at the same time selling another drug, with equivalent if not greater safety concerns, which is claimed to treat the condition that it created in the first place.