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.

The agency cleared J&J's Invokana tablets for adults with Type 2 diabetes. The once-a-day medication works by blocking the kidneys from reabsorbing sugar, which occurs at higher levels in patients with diabetes than in healthy patients. Regulators highlighted the drug as the first in a new class of medications that could help address the growing U.S. diabetes epidemic.

Analysts estimate Invokana could eventually grow into a blockbuster drug, generating more than $1 billion in sales annually for J&J.

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. These patients are at higher risk for heart attacks, kidney problems, blindness and other serious complications. Diabetics often require multiple drugs with different mechanisms of action to control their blood sugar levels.

Invokana differs from older drugs that work by shrinking the amount of sugar absorbed from food and stored in the liver. The most common side effects of Invokana are yeast infections and urinary tract infections, due to the higher amounts of sugar passing through a patient's urine. The drug also can cause a sudden drop in blood pressure when a patient stands up, which can lead to dizziness or fainting, according to the FDA.

The FDA said it approved the drug based on nine studies involving more than 10,000 patients. The studies showed that Invokana, both alone and in combination with other diabetes drugs, helped control blood sugar levels.

"We continue to advance innovation with the approval of new drug classes that provide additional treatment options for chronic conditions that impact public health," said Dr. Mary Parks, director of the FDA's division of endocrinology products.

Regulators are requiring Johnson & Johnson to conduct five follow-up studies to assure the drug's safety. The company will track rates of heart problems, cancer, pancreatitis and liver abnormalities, among other issues.

In recent years, the FDA has required companies developing diabetes drugs to closely monitor all heart-related side effects in patients. That's because diabetes medicines are taken daily for many years, and one former blockbuster, GlaxoSmithKline PLC's Avandia, was linked to higher heart attack risks. In 2010, the FDA restricted Avandia's use to patients not helped by any other diabetes treatments, and European regulators banned sales of Avandia completely.

Last year the FDA rejected a similar experimental drug in the same class, dapagliflozin, from partners Bristol-Myers Squibb Co. and AstraZeneca PLC. The FDA cited concerns about possible liver damage and elevated rates of bladder and breast cancer.

Explore further: FDA questions safety of experimental diabetes drug

shares

Related Stories

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.

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.

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.

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.

New type 2 diabetes drug helps lower blood sugar: study

March 20, 2012
(HealthDay) -- A new type of medication for type 2 diabetes helps to lower blood sugar levels when used in concert with insulin and other diabetes drugs, new research suggests.

ACP recommends metformin to treat type 2 diabetes based on CE analysis of oral medications

February 6, 2012
The American College of Physicians (ACP) recommends that clinicians add metformin as the initial drug treatment for most patients with type 2 diabetes when lifestyle modifications such as diet, exercise, and weight loss have ...

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.