IBJNews

Lilly competitor gets backing on diabetes drug

Back to TopCommentsE-mailPrint

Johnson & Johnson, the world’s largest seller of health-care products, won the backing of U.S. advisers for a diabetes pill the company is seeking to make the first in a new family of drugs for managing blood sugar.

J&J is trying to beat to market similar drugs in development from Indianapolis-based Eli Lilly and Co., Boehringer Ingelheim GmbH, Bristol-Myers Squibb Co. and AstraZeneca Plc.

J&J submitted sufficient evidence that the drug canagliflozin is safe and effective, the panel of advisers to the Food and Drug Administration determined Thursday in a 10-5 vote. The panel also voted 8-7 that the New Brunswick, N.J.-based company’s pill raises concern about heart risks.

The once-a-day pill that expels sugar in the urine after it’s filtered from blood by the kidneys is part of a treatment group known as SGLT2 inhibitors that are intended to have fewer side effects, such as low blood sugar and weight gain, than current diabetes drugs.

“I have to say I found this drug very encouraging,” Rebecca Killion, a patient representative on the panel from Washington, D.C., said during the meeting. While the drug has some risks, it still “addresses concerns that patients have with struggling with weight loss that affects their disease and concerns all diabetics have with struggling with hypoglycemia.”

The FDA is scheduled to decide on canagliflozin by the end of March.

FDA staff said in a report earlier this week that while J&J’s studies showed the drug worked as well Merck & Co.’s second best-seller Januvia and a generic treatment called glimepiride, it may have heart risks. Studies for the drug J&J has proposed calling Invokana to treat adults with Type 2 diabetes showed a potentially higher risk for heart events in the first 30 days compared with a placebo, according to the Jan. 8 report.

J&J submitted interim results of a study called Canvas on the medicine’s cardiovascular effects.

The studies reviewed so far showed that during the first 30 days of the cardiovascular trial, 13 cardiovascular events occurred on canagliflozin and one on placebo, according to the FDA staff. The drug raises LDL, or bad cholesterol, which may lead to the heart risk, despite favorable changes in HDL, or good, cholesterol, blood pressure and body weight, staff said.

“It is unclear whether this is a spurious finding or a true increased risk of early CV events,” agency’s staff said.

Panel members said the only way to answer the question is to let J&J finish their trial.

J&J plans to complete its review of heart risks in 2015, the company said at the meeting.

Some panel members raised concern that the drug doesn’t work as well in diabetics who have moderate kidney impairment, a condition that can occur more often in those with the disease. At the same time, those patients also suffer increased side effects while on the medication.

“It is quite different in them than it is in the general population,” Julia Lewis, a professor of medicine in the Nephrology Department at Vanderbilt University School of Medicine in Nashville, Tenn. “I’m concerned about it doing more harm than good in them.”

Diabetes is the seventh-leading cause of death in the U.S., according to the Centers for Disease Control and Prevention. The disease, defined by high levels of sugar in the blood, affected almost 26 million people in the U.S. in 2010, or about 8.3 percent of the population, the Atlanta-based CDC said.

“We are pleased with the positive recommendation from the committee and look forward to working with the FDA to bring this important new therapy to patients in the U.S.,” Peter Stein, the head of metabolism development and diabetes disease area leader at J&J’s Janssen unit, said in a statement.

There are 11 groups of diabetes drugs on the market, said Osama Hamdy, director of the obesity and inpatient diabetes programs at the Joslin Diabetes Center affiliated with Harvard Medical School in Boston. Most of the treatments stimulate the pancreas to secrete insulin or improve the body’s sensitivity to insulin, a hormone that helps control blood sugar.

SGLT2 inhibitors, like the one J&J developed, don’t cause low blood sugar or weight gain. As the first to work on the kidney, these drugs can be combined with any other diabetes medications for maximum effect, Hamdy said by phone.

Lilly and Boehringer Ingelheim, a closely held company based in Ingelheim, Germany, plan to apply for approval this year of their SGLT2 inhibitor empagliflozin, the companies said Jan. 7 in a statement.

New York-based Bristol-Myers and London-based AstraZeneca are working to address FDA concerns with their product dapagliflozin, and may resubmit an application for review in the middle of this year. The FDA sought more data on dapagliflozin after advisers determined the risks of bladder and breast cancer outweigh the benefits of the medicine.

J&J’s canagliflozin doesn’t show an increased risk of such malignancies, FDA staff said.

ADVERTISEMENT

Post a comment to this story

COMMENTS POLICY
We reserve the right to remove any post that we feel is obscene, profane, vulgar, racist, sexually explicit, abusive, or hateful.
 
You are legally responsible for what you post and your anonymity is not guaranteed.
 
Posts that insult, defame, threaten, harass or abuse other readers or people mentioned in IBJ editorial content are also subject to removal. Please respect the privacy of individuals and refrain from posting personal information.
 
No solicitations, spamming or advertisements are allowed. Readers may post links to other informational websites that are relevant to the topic at hand, but please do not link to objectionable material.
 
We may remove messages that are unrelated to the topic, encourage illegal activity, use all capital letters or are unreadable.
 

Messages that are flagged by readers as objectionable will be reviewed and may or may not be removed. Please do not flag a post simply because you disagree with it.

Sponsored by
ADVERTISEMENT

facebook - twitter on Facebook & Twitter

Follow on TwitterFollow IBJ on Facebook:
Follow on TwitterFollow IBJ's Tweets on these topics:
 
Subscribe to IBJ
  1. So the Mayor adds another non value added layer to having a vehicle towed? Whereby the City Government RECIEVES AN ILLEGAL KICKBACK FROM A LGOISTICS COMPANY THAT SUBS THE WORK TO LOCAL TOW COMPANIES? What is the service the City performs for receiving the "tribute"? This is RICO!!!!! What a corrupt and unnecessary layer. What a dirtbag Mayor and his cronies.

  2. Owner occupied housing. Clear enough?

  3. So people think I am paranoid. It's from experience in dealing with puds requested by developers who make major donations themselves to representatives, have nice fund raisers for those running for office and hide through pac's. then there are the public relation firms. You will note some pr comments below. You there Clyde Lee? My opinion. Commercial along 421, great. Multifamily housing, terrible idea that will change the town. Senior condos or zero lot line homes west, great. I suggest keeping all entries to commercial areas at 421. All entries to owner occupied on sycamore. Will keep the traffic on sycamore down some. Two other things. You can't trust what will be there in 10 years. Steve builds quality stuff, but areas change over time. Look at the changes at the wall mart center at 86th and 421 over the last 10 years. Look at the apartments and neighborhoods behind St Vincent's. Raintree properties WILL decrease in value if commercial and multifamily goes in near. It has already been happening around the bridges area. The houses that have been sold recently are way below market. Several deals not closed due to the Illinois construction and the whole unsurety of the bridges. It's pretty simple, Zionsville will approve the whole thing because the city council has been groomed over a LONG period of time for this. I might even suggest some are in their position as a result of this.

  4. Esta, do you have a dog in this fight? You seem to really want to knock anyone against this project. No, I didn't move to Indiana for the architecture. I moved here for that red barn in the field. The horses and fields of corn. A place that is NOT overdeveloped. There are plenty of nearby places in Indianapolis that could be REDEVELOPED instead.

  5. RKW - OK, we get it, you're paranoid. The question is, are you paranoid enough? Greg - Yes, Pittman(s) is (are) at it again. They are developers, they build things. It's what they do. So when you go to work tomorrow, Greg, you're at it again too. Cliff - Really? You moved to Indiana for its progressive architecture? That's like moving to England for the cuisine. Zionsvillain - The house you moved to was once a field or woods. I'm willing to bet folks were upset when that ground was plowed under and a house was built. But I guess now that you are in, everything should stop? "My house was OK, but the next one is sprawl." SE Guy - Please don't paint us with such a wide brush. Most reasonable Zionsville residents welcome planned, measured development.

ADVERTISEMENT