FDA rejects again Xarelto ( Janssen/Bayer) for treatment of Acute Coronary Syndrome
The FDA has rejected for the second time, the supplemental new drug application for Xarelto (rivaroxaban) from Janssen Pharma/Bayer as a therapy to reduce the risk of cardiovascular events in patients with Acute Coronary Syndrome (ACS). The drug was rejected last June after the Cardiovascular and Renal Drugs Advisory Committee a month earlier voted 6-4, with one abstention, against approval for Xarelto in ACS, a term which includes the conditions of unstable angina, ST-elevation myocardial infarction (STEMI) and non-STEMI.
The advisory committee raised concerns about missing data � or "missingness" � and the increased risk of bleeding events. Indeed, just over 2,400, or 15.5%, of patients dropped out of Janssen's study prematurely, including 1,294, or about 8%, who withdrew their consent. In addition, over 1,000 patients at the end of the trial had an unknown vital status, with incomplete follow-up.
On September 6, 2012, Janssen submitted to the FDA important data related to patients who had withdrawn from the ATLAS ACS 2 TIMI 51 trial (Anti-XaTherapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome) as part of its complete response.
To compile these data, the company undertook a global effort and was able to confirm the vital status information for 843, or 63%, of the 1,338 trial participants who previously had unknown vital status. The mortality benefit observed during the treatment phase of the study was maintained. These new events were distributed equally between the three treatment groups (2.5 mg, 5 mg and placebo) of patients who were alive (806) and those who had died (37). After these efforts, follow up data was not available on only 2.4% of patients.
See the full press release at: http://www.jnj.com/connect/news/all/FDA-Issues-Complete-Response-Letter-for-XARELTO-rivaroxaban-for-the-Reduction-of-Cardiovascular-Events-in-Patients-with-Acute-Coronary-Syndrome
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