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
No positions in stocks mentioned.
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