US approves diabetes drug with new approach (Update)

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.

not rated yet
add to favorites email to friend print save as pdf

Related Stories

Experimental diabetes drug makes comeback

Dec 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)

Mar 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.

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

Jan 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.

Recommended for you

Health care M&A leads global deal surge

10 hours ago

In a big year for deal making, the health care industry is a standout. Large drugmakers are buying and selling businesses to control costs and deploy surplus cash. A rising stock market, tax strategies and ...

US approves new, hard-to-abuse hydrocodone pill (Update)

Nov 20, 2014

U.S. government health regulators on Thursday approved the first hard-to-abuse version of the painkiller hydrocodone, offering an alternative to a similar medication that has been widely criticized for lacking ...

Soaring generic drug prices draw Senate scrutiny

Nov 20, 2014

Some low-cost generic drugs that have helped restrain health care costs for decades are seeing unexpected price spikes of up to 8,000 percent, prompting a backlash from patients, pharmacists and now Washington ...

Only half of patients take their medications as prescribed

Nov 20, 2014

The cost of patients not taking their medications as prescribed can be substantial in terms of their health. Although a large amount of research evidence has tried to address this problem, there are no well-established ...

User 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.