J&J Wins U.S. Approval for First-in-Class Diabetes DrugAnna Edney
Johnson & Johnson, the world’s largest seller of health-care products, won approval for the first in a new family of diabetes drugs, giving them the edge against rivals developing similar medicines.
The U.S. Food and Drug Administration cleared the drug, known as canagliflozin, to treat adults with Type 2 diabetes, the agency said yesterday in a statement. It may generate $800 million in peak sales, Tony Butler, an analyst at Barclays Plc in New York, said in a telephone interview.
The treatment, to be sold under the name Invokana, expels sugar in the urine after the kidneys filter it from the blood. The FDA has required New Brunswick, New Jersey-based J&J to conduct five post-market studies to track possible health risks, including to the heart, bones and pancreas.
“Bringing a new class to market is exciting,” said Kirk Ways, the drug’s development team leader, in a telephone interview. “We need to do better as a nation treating diabetes. Bringing canagliflozin to market will give patients and physicians another option.”
Invokana is part of a family of medicines known as SGLT2 inhibitors intended to have fewer side effects, such as low blood sugar and weight gain, than currently approved diabetes drugs. The company is trying to beat to market similar drugs being developed by Eli Lilly & Co., Boehringer Ingelheim GmbH, Bristol-Myers Squibb Co. and AstraZeneca Plc.
26 Million People
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.
While J&J has struggled with recalls and lawsuits over products such as metal hip implants and over-the-counter children’s medicines, the company has gained approval the past two years for new prescription drugs such as the tuberculosis tablet Sirturo, the prostate cancer pill Zytiga and the blood thinner Xarelto. Zytiga generated $961 million in 2012 sales.
For canagliflozin, J&J must study the medicine’s effect on patients’ hearts while the drug is on the market. J&J is working on a cardiovascular study called Canvas that the company plans to complete in 2017, Ways said.
During the first 30 days of treatment, 13 cardiovascular events occurred out of 2,886 patients on canagliflozin in the Canvas trial and one of 1,441 patients taking placebo, according to a January report from 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.
Invokana probably will be used by doctors as an option after patients fail current therapies, such as Merck & Co’s $4.1 million best-seller Januvia, and cheaper generics including metformin, Butler said.
“What we tried to do with our development program was look across the spectrum,” Ways said. “What we tried to do is arm physicians with the information to prescribe this drug for patients they thought would benefit best.”
Butler’s sales estimate is lower than other diabetes drugs because of the medication’s link to an increased risk of urinary tract infections, particularly in women. Females also experienced an increased risk of vaginal infections.
“I worry its use in women will be somewhat minimal,” Butler said.
Most diabetes treatments on the market stimulate the pancreas to secrete insulin or improve the body’s sensitivity to insulin, a hormone that helps control blood sugar. As the first to work on the kidneys, SGLT2 inhibitors, like the one J&J developed, can be combined with other diabetes medications.
Boehringer, based in Ingelheim, Germany, and Lilly, based in Indianapolis, submitted an application for FDA approval of their SGLT2 inhibitor empagliflozin, the companies said in a March 25 statement. Astellas Pharma Inc. is also working on an SGLT2 inhibitor known as ipragliflozin.
New York-based Bristol-Myers and London-based AstraZeneca are working to address FDA concerns with their product dapagliflozin. 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.