A New J&J Diabetes Pill, Heart Risks & FDA Approval

Another horse race is under way in the diabetes market and Johnson & Johnson is hoping to become the first entrant to sell a treatment known as a SGLT2 inhibitor. The question is whether an unclear cardiovascular risk will prompt the FDA to await final results of a key study, which would delay J&J from selling its drug and intensify the battle. In advance of an FDA advisory committee meeting this week, agency medical reviewers released a briefing document that noted a concern of high major adverse cardiovascular events during the first 30 days after taking J&J’s canagliflozin in its CANVAS cardiovascular outcomes study. At the same time, though, the FDA staffers acknowledge that it is uncertain whether the “observed imbalance… might be attributable to chance” (here is the FDA review). Moreover, the increased cardiovascular risk seemed to have vanished after 30 days. So does the FDA wait for the final CANVAS study results or address the issue in product labeling? Why would the FDA wait? In 2008, you may recall, the agency issued new guidance that recommends all new Type 2 diabetes drugs must demonstrate they do not increase the risk of cardiovascular events. And as Wells Fargo analyst Larry Biegelsen notes, the agency included “very specific statistical criteria for proving cardiovascular safety.” The FDA took that step in the wake of the controversy over the Avandia diabetes pill sold by GlaxoSmithKline (GSK), which was accus...
Source: Pharmalot - Category: Pharma Commentators Authors: Tags: Uncategorized AstraZeneca Avandia Boehringer Ingelheim Bristol Myers Squibb Diabetes Eli Lilly FDA GlaxoSmithKline Januvia JJ Johnson & Johnson Merck Type 2 Diabetes Source Type: blogs