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FDA reviews Xarelto’s pulmonary embolism and DVT benefit

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Pharmaceutical giants Johnson & Johnson and Bayer are attempting to squeeze as many uses out of their jointly manufactured drug Xarelto as possible and have requested extended approval to treat other blood clot conditions. The U.S. Food and Drug Administration has agreed to review Xarelto under priority status, meaning a decision may be reached within six months instead of ten.

The companies asked the FDA to extend approval of Xarelto to treat and prevent recurrence of two deadly blood clot-related conditions known as deep vein thrombosis, in which a blood clot forms in the deepest veins of the body like the legs, and pulmonary embolism. Deep vein thrombosis can lead to pulmonary embolism if large blood clots travel to and block the arteries that branch into the lungs.

If approved, “Xarelto has the potential to address critical unmet needs in treating patients with these serious medical conditions,” said Johnson & Johnson subunit Janssen Pharmaceuticals’ vice president, Dr. Paul Burton, in a statement.

Deep vein thrombosis and pulmonary embolism affect 900,000 people each year and kill a third of them, according to a study published in the American Journal of Preventative Medicine.

The FDA rejected Janssen Pharmaceuticals’ June request to approve Xarelto to reduce heart attack and stroke risk in patients with acute coronary syndrome, or sudden reduced blood flow to the heart, according to the New York Times.

Xarelto was originally approved in 2011 to prevent blood clots in patients who’d recently undergone knee or hip replacement surgery and to treat an abnormal heart rhythm condition called atrial fibrillation.

Xarelto is vying with Pradaxa and Eliquis to steal the attention away from warfarin, an anticlotting drug that has been around since the 1950s. Warfarin is a far cheaper drug, but it’s considered more problematic to patients since it requires frequent monitoring dose adjustments.

The NYT noted that drug companies often try to "compensate for the loss of revenue from best-selling drugs that have lost patent protection in recent years. One popular strategy is to squeeze as many uses as possible out of drugs that still have patent exclusivity."

With that in mind, what do you think? Should the FDA extend approval to treat deep vein thrombosis and pulmonary embolism? We welcome your comments.