The third time was not the charm for Johnson & Johnson and its blood thinner Xarelto (Rivaroxaban).
Regulators at the U.S. Food and Drug Administration (FDA) have decided not to expand the drug into a secondary use, to prevent new heart attacks and strokes and to prevent the clogging of heart stents in patients who have acute coronary syndrome (ACS), any sudden blockage of blood flow in the heart. This was the third time the FDA has denied the application for the treatment of ACS.
In January an expert advisory committee voted overwhelmingly to deny approval for the expanded use.
Xarelto is co-marketed by Johnson & Johnson and Bayer and the two companies have been trying to push the agency for expanded use since it was approved. Expanded use can put a drug in the blockbuster category bring more profit to shareholders.
The advisory panel to the FDA declined the application for Xarelto because there was missing data necessary to assess the drug’s benefit. This is not the first time missing data has been a problem. In late 2011, J&J filed for the expanded approval but the FDA cited missing data then as well. J&J came back with some additional data but again, the expanded use of the drug was denied. J&J appealed.
In 2011, the FDA issued a report on the Novel New Drugs of 2011. Xarelto was one of the drugs that received funding from industry so the FDA could conduct its review for new products within a targeted time frame under the Prescription Drug User Fee Act (PDUFA). In other words, the companies were pinning a lot of hope on the success of Xarelto.
More than two million Americans suffer from this type of abnormal heart rhythm where the heart beat is irregular and not coordinated in the two upper chambers of the heart. The condition can cause blood to pool in the chambers and can result in blood clots.
Rivaroxaban remains available to be prescribed to patients with non-valvular atrial fibrillation, or an irregular heartbeat, to prevent blood clots and strokes. It is frequently prescribed following knee and hip surgery to prevent a blood clot.