J&J Experimental Diabetes Drug Helps High-Risk Patients

Johnson & Johnson (JNJ)’s experimental diabetes drug lowered blood sugar for the most vulnerable patients in two studies, including older people who struggle to control the condition and those at high risk of heart disease.

Two company-funded studies presented today at the European Association for the Study of Diabetes in Berlin found side effects included infections and lowering blood pressure and blood sugar too far in some patients. The drug may be the first to reach the U.S. market after Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc (AZN) failed to win approval in January of a rival medicine, dapagliflozin, because of cancer and safety concerns.

The number of people with diabetes is surging worldwide as the population ages and grows heavier. The U.S. Centers for Disease Control and Prevention estimates 1 in 3 Americans may be diabetic by 2050. Drugs to treat the condition generated $39.2 billion in 2011, making it the third-largest market for pharmaceuticals. Still, millions of people fail to get their blood sugar to target levels, leading to new drug development.

“These studies are to test whether this mechanism and this drug will be safe and well-tolerated in these more vulnerable populations,” said Kirk Ways, canagliflozin development team leader for New Brunswick, New Jersey-based J&J. “It’s important for regulators and physicians to see this information. The efficacy data is encouraging and the safety results were similar to those seen in less-vulnerable populations.”

FDA Filing

The results support the company’s May filing for U.S. Food and Drug Administration approval of canagliflozin, Ways said in a telephone interview.

J&J fell less than 1 percent to $68.96 at the close in New York. The shares have gained 8.3 percent in the past 12 months.

Canagliflozin and similar drugs known as SGLT2 inhibitors block the kidneys from routing sugar taken from the blood back into the body, and instead excrete it in the urine. Existing diabetes drugs decrease sugar production or increase levels of the hormone insulin that convert the sugar to energy.

While the industry has struggled to prove the novel medicines are safe for long-term use and significantly improve health, about a dozen are in development. Eli Lilly & Co. (LLY) and Boehringer Ingelheim GmbH’s empagliflozin, Roche Holding AG (ROG) and Chugai Pharmaceutical Co.’s tofogliflozin and Astellas Pharma Inc. (4503)’s ipragliflozin are in the final stages of study.

Study Results

Adding J&J’s canagliflozin to standard treatment for 18 weeks significantly lowered blood sugar in part of a late-stage study of 1,718 patients at high risk for heart disease who had already been taking insulin for an average of 7.1 years. Patients on the drug lost more weight and had lower blood pressure than those given a placebo, while cholesterol levels and hypoglycemia rates rose. Genital and urinary tract infections, low blood pressure and increased urination were also more common.

A second late-stage study found adding canagliflozin to existing therapy for six months helped control blood sugar levels in 714 patients with an average age of 64 who were struggling with the disease. Low blood sugar was more common in patients getting the drug than those given a placebo, with one person experiencing a severe episode, the study found.

“The low blood pressure events were not serious and, as expected in patients on insulin under better glucose control, hypoglycemia rates were increased,” Ways said.

To contact the reporter on this story: Michelle Fay Cortez in Minneapolis at mcortez@bloomberg.net

To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net

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