Johnson & Johnson (JNJ) Diabetes Pill May Have Heart Risks, FDA Staff Says  
1/8/2013 8:27:26 AM

Johnson & Johnson (JNJ)’s experimental diabetes pill may carry heart risks, U.S. regulators said in a review that threatens to delay the company’s first-to-market status among a new family of medicines. Studies for the drug canagliflozin, which expels sugar in the urine after it’s filtered from blood by the kidneys, showed a potentially higher risk for heart events in the first 30 days compared with a placebo, Food and Drug Administration staff said today in a report. An FDA advisory panel is set to meet Jan. 10 to make recommendations to the agency on the drug. The once-a-day pill is J&J’s effort to be the first to market with a new class of diabetes treatments known as SGLT2 inhibitors aimed at cutting side effects from current drugs. The drugs are also being developed by Eli Lilly & Co. (LLY), Boehringer Ingelheim GmbH, Bristol-Myers Squibb Co. (BMY) and AstraZeneca Plc. (AZN). A delay to further assess risk “could erase its first mover advantage,” Lawrence Biegelsen, an analyst with Wells Fargo Securities in New York, wrote in a note to clients yesterday. “A first-to-market position is an important marketing advantage in this arena.” J&J, based in New Brunswick, New Jersey, fell less than 1 percent to $71.37 at 9:34 a.m. New York time. Canagliflozin, may generate $446 million in sales in 2016 if approved, according to the average estimate of three analysts surveyed by Bloomberg. The drugmaker has proposed marketing canagliflozin under the name Invokana for adults with Type 2 diabetes. It worked as well against diabetes in clinical trials as Januvia, Merck & Co.’s second-best selling drug, and a generic treatment called glimepiride, FDA staff said.