Why the FDA Still Won’t Approve J&J’s Blood Clot Medicine


The Food and Drug Administration has yet again rejected Johnson & Johnson‘s (NYSE:JNJ) application for the expanded approval of Xarelto, the Wall Street Journal reported on Friday.

Johnson & Johnson has been seeking expanded approval for its anti-blood clotting medicine in order to treat patients with acute coronary syndrome who are at an increased risk of heart attacks and strokes in addition to the drug’s current approved use as a preventative medicine for patients with pulmonary deep-vein thrombosis, pulmonary embolism, and to reduce risk of stroke and heart attack in patients with irregular heartbeats, known as atrial fibrillation.

Xarelto, which is taken orally, works to lessen the risk of stroke and heart attack by acting as an anti-blood clotting agent, per Johnson & Johnson.

The FDA on Friday also rejected an application by the company for the expanded approval of the same drug, this one sought to gain approval for use of the drug in the same patient population in order to reduce the risk of stent thrombosis, a rare condition that occurs when a blood clot forms on the stent, which can have serious complications, the Journal reports.

The FDA’s decision doesn’t come as a surprise to those following Johnson & Johnson’s failed attempts at gaining expanded approval for the drug. Last month, an agency advisory panel said that it wouldn’t recommend approval of the drug, citing a huge chunk of missing data from one of the company’s pivotal late-stage trials in patients with ACS. Johnson & Johnson has since attempted to restore and make up for the missing data, but the FDA has remained unswayed, claiming the information is too unreliable.

Johnson & Johnson first filed for expanded approval of the drug for use in patients with ACS in 2011 according to the Wall Street Journal. This marks the company’s third rejection for expanded approval for the drug in ACS patients and the second rejection for a stent thrombosis indication.

“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,” said Paul Burton, Janssen Research & Development vice president, in a statement on Friday, per the Wall Street Journal.

Johnson & Johnson spokeswoman Kristina Chang said, ”We are not disclosing the details because we are still evaluating the contents and our next steps,” per Reuters.