FDA Turns Down J&J's Bid for Expanded Xarelto Use

Health-care giant Johnson & Johnson (NYSE: JNJ  ) recently released a press statement that said that the FDA has turned down its bid to receive approval to treat patients with acute coronary syndrome (ACS) with Xarelto, the anticoagulant marketed by J&J subsidiary Janssen Pharmaceuticals, and Bayer.

Xarelto already holds approvals for six other indications in the United States, including for the treatment of atrial fibrillation. However, with an estimated 1.2 million Americans hospitalized for ACS each year, Johnson & Johnson had its eyes set on a sizable market, and significant revenue for the drug.

Janssen Vice President Dr. Christopher Nessel maintained an optimistic outlook in J&J's statement, saying, "We remain confident in the robustness and results of the ATLAS ACS 2 TIMI 51 trial, evidenced by a significant reduction in cardiovascular events ... We will continue to work with the FDA to address their questions."

The rejection marked the second time the FDA has passed on Xarelto's use to treat ACS. The agency first denied Johnson & Johnson last June, turning down the drug due to bleeding risks and missing trial data.

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