The FDA Turns Down Janssen's Xarelto The Third Time
By Cyndi Root
Janssen Research & Development, LLC (Janssen) announced in a press release that the Food and Drug Administration (FDA) turned down Xarelto for the third time. The federal agency issued two complete response letters (CRLs) regarding Janssen’s supplemental New Drug Applications (sNDAs). Janssen had applied to use Xarelto (rivaroxaban) for patients with acute coronary syndrome (ACS) and for those with stent thrombosis. Paul Burton, M.D., Ph.D., Vice President, Clinical Development, Janssen Research & Development said, “We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events.” He added that they are reviewing the letters to determine the next steps.
Acute Coronary Syndrome
Acute coronary syndrome (ACS) is a secondary cardiovascular condition, a complication of heart disease. A stroke or heart attack occurs when a blood clot forms and reduces blood flow to the heart. Over a million people each year are diagnosed with ACS.
Stent Thrombosis
Stents are used in heart surgery as an alternative to balloon angioplasty. Stent thrombosis occurs when the stent causes clots to form, blocking the flow of blood. Consequences are myocardial infarction, angina, and death.
Xarelto
Xarelto (rivaroxaban) is an anticoagulant. It blocks Factor Xa, a blood clotting factor. Rivaroxaban has been studied extensively in clinical trials. Janssen based its sNDAs on a Phase 3 clinical trial. The study was titled, “Phase 3 ATLAS ACS 2 TIMI 51 (Anti-Xa Therapy to Lower cardiovascular events in Addition to aspirin with/without thienopyridine therapy in Subjects with Acute Coronary Syndrome).” The evidence from that trial was published in the New England Journal of Medicine and presented at the American Heart Association’s annual meeting.
FDA Decision
The response letters do not come as a surprise, since the Cardiovascular and Renal Drugs Advisory Committee voted in January to decline the use of Xarelto for ACS. In advance of the meeting, the committee published a guide to rivaroxaban, including its regulatory history and the outstanding issues under consideration. It states that four out of five topics that the FDA needed addressed had been addressed and did not present a barrier to approval. However, the committee had doubts about the clinical evidence presented. It suggested that Janssen consider modifying the time period for using the drug.
Source:
http://www.janssenrnd.com/sites/default/files/pdf/Janssen_ACS-Stent%20CRL_Press%20Release_FINAL.pdf