FDA Again Rejects ACS Indication for Rivaroxaban (Xarelto) Reply

For the second time the FDA has turned down the supplemental new drug application (NDA) for the proposed indication of rivaroxaban (Xarelto, Johnson & Johnson) to treat patients with acute coronary syndrome (ACS).

In a new press release issues on Monday afternoon, the company restated its confidence “in the robustness and results of the ATLAS ACS 2 TIMI 51 trial.” Criticism of ATLAS from the FDA and the advisory panel members had focused on missing data from the ATLAS trial. In today’s press release J&J provided more information about its efforts to address this question:

Click here for the complete story on Forbes.

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