Sorry!! The article you are trying to read is not available now.
Thank you very much;
you're only a step away from
downloading your reports.

Johnson & Johnson Diabetes Medicine Faces Big Test


J&J wants to enter a new drug treatment area, but potential heart risks for an experimental therapy must first be addressed. On Thursday, government advisers will weigh in on whether Invokana should be approved for the US market.

Johnson & Johnson (NYSE:JNJ) takes a critical step toward approval of a new diabetes drug Thursday, but it must first answer questions about the medicine's safety.

In documents prepared for a panel of US government advisers released Tuesday, staff reviewers for the Food and Drug Administration said J&J's experimental therapy, Invokana, appears to work but also may have some safety risks that need to be discussed before any approval is granted for the product.

Side effects for the drug, also known as canagliflozin, are being examined by government officials. FDA reviewers appear to be most concerned about cardiovascular risk and the drug's effect on kidneys. The heart risk is front and center and it will be the first topic of discussion for the expert panelists after they spend hours listening to FDA staff, company presenters, and others debating the drug at a public hearing Thursday. The first voting question for the panelists will assess cardiovascular risk. The recommendation will be considered by the FDA as it decides whether to approve the drug.

As always, the experts and, ultimately, the FDA will weigh the benefits vs. the risks of the drug. FDA staff spent a good portion of a review of Invokana talking about the heart risks. See the briefing document here. See the draft questions for the panel here.

The stakes are high for J&J. The company sells blood glucose monitoring and insulin delivery products through its medical devices and diagnostics division, but it wants to break into the prescription medicine market for diabetes. Invokana treats blood sugar levels in patients with type 2 diabetes, the most common form of the disease. The drug is part of a class of treatments known as SGLT2 inhibitors. The FDA already rejected a drug in this class, dapagliflozin, early last year. That drug, developed by Bristol-Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN), was approved in Europe in November where it will be sold under the brand name Forxiga. Eli Lilly (NYSE:LLY) and partner Boehringer Ingelheim just reported positive results for its SGLT2 inhibitor in a late-stage trial. Those companies also are seeking approval.

J&J is conducting a massive -- more than 10,000 patient -- study to test its diabetes drug. In total, the company is conducting nine clinical trials around the world with almost 10,300 patients. J&J says it's the largest late-stage study of any experimental drug for type 2 diabetes ever performed.

Asked to comment on the safety profile of the drug, J&J spokeswoman Christina Chan provided a statement that said the trials "suggest that canagliflozin has the potential to help control blood glucose in a wide range of patients with type 2 diabetes. It may also provide other potential benefits including weight loss and reductions in blood pressure in these patients. We look forward to presenting these results to the advisory committee."

Shares of J&J rose less than 1% to $71.51 Tuesday. The stock jumped more than 10% in the past 12 months.

Full meeting information and briefing documents for the FDA panel can be found here.

Twitter: @brettchase

Follow the markets all day every day with a FREE 14 day trial to Buzz & Banter. Over 30 professional traders share their ideas in real-time. Learn more.
< Previous
  • 1
Next >
No positions in stocks mentioned.
The information on this website solely reflects the analysis of or opinion about the performance of securities and financial markets by the writers whose articles appear on the site. The views expressed by the writers are not necessarily the views of Minyanville Media, Inc. or members of its management. Nothing contained on the website is intended to constitute a recommendation or advice addressed to an individual investor or category of investors to purchase, sell or hold any security, or to take any action with respect to the prospective movement of the securities markets or to solicit the purchase or sale of any security. Any investment decisions must be made by the reader either individually or in consultation with his or her investment professional. Minyanville writers and staff may trade or hold positions in securities that are discussed in articles appearing on the website. Writers of articles are required to disclose whether they have a position in any stock or fund discussed in an article, but are not permitted to disclose the size or direction of the position. Nothing on this website is intended to solicit business of any kind for a writer's business or fund. Minyanville management and staff as well as contributing writers will not respond to emails or other communications requesting investment advice.

Copyright 2011 Minyanville Media, Inc. All Rights Reserved.
Featured Videos