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.
(AP)
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2 Responses
Mandating intensive exercise and restrictive diet cost less (and perhaps cost nothing), and would be far more effective with the only side effect being the need for a new wardrobe once one loses weight (okay, diet and exercise would result in a longer lifespan and feeling more fit so you might spend more money over time). Treating the symptoms (high blood sugar) make no sense – one should treat the cause (too much food, too little exercise).
Akuperma – what you propose is prevention, which is great until someone gets sick, once they have Diabetes you do need to treat the symptoms because when left untreated they do a lot more damage…
And pray do tell me how you are going to force people to eat and live healthy in a country where downsizing a soda cup is considered an infringement of liberties.