FDA Concerned With J&J's Xarelto Indication For ACS
The FDA recently released a statement regarding the recommended use of Xarelto (Rivaroxaban), an anticoagulant drug manufactured under Janssen Research & Development, a subsidiary of Johnson & Johnson. Xarelto is an oral medication, marketed as a drug that reduces the risk of thrombotic cardiovascular events if used in patients with Acute Coronary Syndrome (ACS). Xarelto is meant to be used as part of a combination therapy with antiplatelet drugs.
Currently, Xarelto is used to treat deep vein thrombosis and pulmonary embolisms. It is also used to reduce the risk of stroke in patients who have an irregular heartbeat that is not already associated with cardiac conditions. Xarelto is also used to reduce the risk of blood clots in these patients. J&J presented the treatment to the FDA with the proposed dosage of 2.5 milligrams two times a day for 90 days. However, the administration showed concerns in regards to how J&J analyzed the data generated by their clinical trials. According to the FDA, the trial presented no significant or convincing proof that the drug offers an improved benefit to patients, as opposed to drugs that are currently on the market; rendering it unnecessary as it does not fill an unmet need.
J&J had presented the drug to the FDA for approval in the treatment of ACS twice beginning in 2011; however both times the administration denied their request prompting the company to seek an appeal. In response to the appeal, the FDA encouraged the company to reduce the treatment duration of the drug to just 30 days, as the side effect of bleeding was less during this duration. J&J issued a new application with the duration of treatment lowered to 90 days.
Recently Dr. Paul Burton, Vice President of Clinical Development at Janssen Research stated the drug “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." He went on to say “We appreciate the thoroughness of the committee's review and continue to believe rivaroxaban, in addition to the current standard of care, may help provide patients with ACS additional protection against life-threatening cardiovascular events such as death, heart attack and stroke. We will work with the FDA to address questions raised today."
The FDA is suggesting there is no clear data that the drug presents a greater benefit over its serious risk of bleeding. Two drugs, Effient (Lilly) and Brilinta (AstraZeneca), are already on the market to treat ACS.
This leaves J&J with a product that cannot be marketed for ACS use. The FDA review stated, "There is no data demonstrating that ACS patients treated with clopidogrel plus rivaroxaban will have superior outcomes compared to treatment with prasugrel or ticagrelor, so rivaroxaban does not provide therapy for an unmet medical need."