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.

The Food and Drug Administration's panel of diabetes experts voted 10-5 in favor of J&J's canagliflozin to treat Type 2 diabetes. The drug is part of a new class of medications that work by increasing the levels of blood sugar excreted via urine.

Panelists said the drug could be useful in combination with existing diabetes medications. However, they raised concerns about low levels of heart attack, stroke and urinary tract infections seen in the first year of testing. The experts said those infections could be especially harmful to patients with kidney damage, a common side effect of diabetes.

Almost all panelists recommended that the company be required to track those problems over the long term to tell whether they get worse.

"There are definitely benefits to this drug, there are also risks," said Dr. Abraham Thomas of the Henry Ford Hospital. "I still have concerns, as many other do."

In recent years, the FDA has required companies developing diabetes drugs to track cardiac side effects in patient testing. That's because diabetes medicines are taken daily for many years, and one former blockbuster, 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 barred all sales of Avandia.

J&J is studying canagliflozin in nine studies enrolling more than 10,000 patients. It notes this is the largest research effort of its kind submitted to FDA for a diabetes drug.

If the FDA approves the New Brunswick, New Jersey company's drug, it would be the first in a new class medicines called SGLT2 inhibitors.

The agency rejected another experimental drug in the SGLT2 class, dapagliflozin from partners Bristol-Myers Squibb Co. and AstraZeneca PLC, a year ago. The FDA cited concerns about possible liver damage and elevated rates of bladder and breast cancer.

The FDA has set a target date of March 31 to decide whether to approve U.S. sales of canagliflozin. Johnson and Johnson would sell it under the brand name Invokana.

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

shares

Related Stories

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.

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 panel supports continued testing of pain drugs

March 12, 2012
(AP) -- A panel of arthritis experts has recommended that the federal government allow continued testing of an experimental class of pain drugs for arthritis, despite links to bone decay and joint failure

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.

Recommended for you

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 ...

Price tag on gene therapy for rare form of blindness: $850K

January 3, 2018
A first-of-its kind genetic treatment for blindness will cost $850,000 per patient, making it one of the most expensive medicines in the world and raising questions about the affordability of a coming wave of similar gene-targeting ...

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.