US approves diabetes drug with new approach (Update)

January 8, 2014 by Matthew Perrone

The U.S. 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. 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.

Explore further: Experimental diabetes drug makes comeback

Related Stories

Experimental diabetes drug makes comeback

December 12, 2013
A panel of federal health advisers has backed the benefits of an experimental diabetes drug that uses a new method to reduce blood sugar, setting aside previous concerns about the pill's safety.

US OKs first-of-its-kind diabetes drug (Update)

March 29, 2013
The U.S. Food and Drug Administration on Friday approved a first-of-its-kind diabetes drug from Johnson & Johnson that uses a new method to lower blood sugar—flushing it out in patients' urine.

EU OKs Bristol-Myers, AstraZeneca diabetes drug

November 14, 2012
(AP)—Drugmakers Bristol-Myers Squibb Co. and AstraZeneca PLC say their experimental diabetes pill has gotten its first major approval, in the European Union.

FDA questions safety of experimental diabetes drug

July 15, 2011
(AP) -- Federal health regulators have concerns about bladder and breast cancer seen in patients taking an experimental diabetes pill from Bristol-Myers Squibb and AstraZeneca.

US panel backs novel diabetes pill from J&J (Update)

January 10, 2013
A panel of U.S. health experts ruled Thursday that an experimental diabetes drug from Johnson & Johnson is safe and effective, though lingering safety questions must be tracked over the long term.

FDA staff: J&J diabetes drug may pose heart risk

January 8, 2013
Federal drug reviewers think Johnson & Johnson's experimental diabetes drug might bring heart risks because it raised cholesterol levels in patient testing.

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.