FDA Advisors Doubt Efficacy of Xarelto (Rivaroxiban) in Reducing Heart Risk
Pivotal efficacy data questioned (January 14)
In a briefing document posted online, the FDA’s Cardiovascular and Renal Drugs Advisory Committee has questioned the ability of Xarelto (rivaroxiban) to reduce the risk of additional heart problems in patients who have experienced a heart attack. Specifically, the reviewers are skeptical about efficacy data from the pivotal ATLAS trial.
The panel’s opinion was posted 2 days ahead of a meeting of outside experts who will discuss the drug and recommend whether it should be approved.
Rivaroxaban is a factor Xa inhibitor that is currently marketed in the U.S. 1) to reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation, and 2) for the prevention and treatment of venous thromboembolism in several settings. The drug’s manufacturer (Janssen) is now seeking approval to use rivaroxaban in the first 90 days after a heart attack.
The reviewers noted, however, that the ATLAS trial was not designed to determine the effectiveness of rivaroxaban for a fixed period after an episode of acute coronary syndrome (ACS), and so no analyses of effect over time were specified.
Therefore, the reviewers concluded: “It is unclear how to choose the metric for determining when the benefit of rivaroxaban is greatest… Not only does the effect of rivaroxaban not appear to be greater earlier, but an effect in the first 90 days or so is not apparent at all.”
The FDA is not obligated to follow the advice of its advisory committees, but it usually does so.