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.