Valentine's was not a lucky day for Johnson & Johnson (J&J) as the U.S. Food and Drug Administration turned down for the third time its supplemental New Drug Application (sNDA) filing for Xarelto.
The sNDA for Xarelto, with a generic name rivaroxaban, seeks for the administration of the drug to patients who suffer from acute coronary syndrome (ACS), to lower their risk of stroke, myocardial infarction, or even death. The regulatory body also declined the sNDA for the same drug that may help reduce heart stent clogging or thrombosis in patients with ACS.
Acute coronary syndrome is a medical condition that refers to the sudden blockage of the blood supply to the heart, such as unstable angina and heart attack. The sudden blockage can lead clotting or bursting of the vessel that will prove fatal for any individual. Chest discomfort or pain is among the primary symptoms of ACS that includes sweating, dizziness, nausea, shortness of breath, and discomfort of the arm, jaw, stomach, or neck.
"This is an absolute medical emergency. Something dramatic, right this minute is going on in the arteries that is hurting the blood flow to the heart," explained American Heart Association (AHA) member Dr. Ann Bolger of the San Francisco General Hospital. "...the heart tissue is dying, even if it's just a few cells or a whole big section of the heart."
The decision of the FDA does not come as a surprise, however, as it following the recommendation made by a panel in January against the use of Xarelto for ACS. Insufficient clinical data presented by J&J to the panel might have been the deal breaker that stopped the drug from getting the green light as treatment for other heart problems.
"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. We are evaluating the contents of the letters and will determine the appropriate next steps," said Janssen Research & Development. vice president for Clinical Development Paul Burton.
The thumbs down of the FDA follows the third attempt by J&J to release Xarelto for ACS. The first application was submitted by the company in 2011 but was then declined due to missing data. A revised application to market the drug was submitted to the authorities later but the appeal was also denied.
At the moment, the anticoagulant drug Xarelto is administered for atrial fibrillation or irregular heartbeat that affects the elderly. It is also being marketed for those who are at risk of developing or have already developed blood clots in one's legs or lungs and people undergoing surgery for knee or hip replacement.
