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

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.

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

Related Stories

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

FDA approves hard-to-abuse narcotic painkiller

10 hours ago

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

10 hours ago

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

11 hours ago

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

Tough-to-abuse formulation of oxycodone approved

11 hours ago

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe pain when other ...

EU regulator: Morning-after pill OK for all women

Jul 24, 2014

(AP)—A commonly used morning-after pill is suitable for use by heavier women, the European Medicines Agency said Thursday after a review of the evidence sparked by the French manufacturer's declaration that the drugs didn't ...

Physicians warned about counterfeit medical devices

Jul 24, 2014

(HealthDay)—Physicians should be aware of the prevalence and serious consequences associated with use of counterfeit medical devices, according to a letter to the editor published online July 20 in Lasers in ...

User comments