WASHINGTON (AP) — The Food and Drug Administration on Wednesday
approved a new diabetes drug from Bristol-Myers Squibb and AstraZeneca
that uses a novel approach to reduce blood sugar.
Farxiga is a once-a-day tablet designed to help diabetes patients
eliminate excess sugar via their urine. That differs from older drugs
that decrease the amount of sugar absorbed from food and stored in the
liver.
The drug is the second product approved in the U.S. from the
new class of medicines known as SGLT2 drugs. In March the FDA approved
Johnson & Johnson's Invokana, which also works by eliminating excess
sugar through patients' urine.
The agency cleared Farxiga tablets for patients with type 2 diabetes,
which affects about 24 million people in the U.S. The approval marks a
comeback for the drug, which was previously rejected last year after
studies raised concerns about links to bladder cancer and liver
toxicity.
Ten cases of bladder cancer were found in patients taking the drug in
clinical trials, so Farxiga's label warns against using it in patients
with the disease. A panel of FDA advisers last month said that the
uptick in cancers was likely a statistical fluke, and not related to the
drug. But the FDA is requiring Bristol and AstraZeneca to track rates
of bladder cancer in patients enrolled in a long-term follow up study.
The companies will also monitor rates of heart disease, a frequent
safety issue with newer diabetes medications.
The most common side effects associated with Farxiga included fungal
and urinary tract infections. The drug can be used as a stand-alone drug
or in combination with other common diabetes treatments, such as
insulin and metformin.
People with type 2 diabetes are unable to properly break down
carbohydrates, either because their bodies do not produce enough insulin
or have become resistant to the hormone, which controls blood sugar
levels. Diabetics often require multiple drugs with different mechanisms
of action to control their blood sugar levels.
New York-based Bristol-Myers Squibb Co. and London-based AstraZeneca
PLC already co-market the diabetes drug Onglyza, which increases insulin
production while reducing glucose production.
Huffington
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