Announcement provided by Ali Sadeghi-Khomami, PhD; Research and Development Manager, Precision BioLogic Inc:
In documents released ahead of an FDA advisory panel meeting on January 16, agency staff on Tuesday expressed skepticism that the data submitted by Johnson & Johnson demonstrate that Xarelto (rivaroxaban) is effective for treating acute coronary syndrome (ACS) in patients with a previous history of heart attack. The drug-maker’s current submission seeks clearance of the therapy for treating acute coronary syndrome for 90 days.
The FDA initially rejected Xarelto for the treatment of acute coronary syndrome in 2012 on concerns that too much information was missing from Johnson & Johnson’s submission to determine whether the therapy was effective. The regulator again declined to approve the drug in March last year although the company indicated that it supplied further data requested by the FDA.
In the documents released on Tuesday, FDA staff specifically questioned the method by which the drug-maker analyzed the clinical trial data citing a lack of evidence that the therapy provides a significant clinical benefit or meets an unmet need. “It is unclear how to choose the metric for determining when the benefit of Xarelto is greatest,” the reviewers commented, adding “not only does the effect of Xarelto not appear to be greater earlier, but an effect in the first 90 days or so is not apparent at all.” Agency staff further remarked that Johnson & Johnson’s therapy is also linked to increased bleeding risks.
Paul Burton, vice president of clinical development at Johnson & Johnson’s Janssen Research and Development, stated that the drug-maker believed that Xarelto in combination with standard treatment “delivers a strong incremental benefit by significantly reducing the risk of cardiovascular events, including death, at a time when patients are at the highest risk.”
Commenting on the news, Wells Fargo analyst Larry Biegelsen said “based on our review of this material, we continue to have low expectation of approval” for this indication, adding “we can expect the acute coronary syndrome potential to be modest, even if approved.” Biegelsen estimates that the drug will generate $1.2 billion in sales in 2015, up from approximately $703 million in 2013.
Xarelto was originally cleared by the FDA for preventing deep vein thrombosis (DVT) in patients undergoing knee or hip replacement surgery in 2011. The therapy later garnered approval the same year for reducing the risk of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF), and the drug’s indication was further expanded in 2012 to include treating and reducing the risk of DVT and pulmonary embolism.