FDA Rejects New Use for Blood Thinner Xarelto
Vote Follows Panel Recommendation From Last Month
June 22, 2012 -- The FDA has decided -- for now -- against allowing the new blood thinner Xarelto to be used to treat patients with blocked coronary arteries.
Federal officials issued a complete response letter late Thursday, which means they want more information from the drug manufacturer before making a final decision.
Xarelto (rivaroxaban) entered the market last summer and is already approved for the prevention of blood clots that form in the blood vessels of the legs and lungs during knee or hip replacement surgery. It is also approved to reduce stroke risk in patients with certain abnormal heart rhythms.
But manufacturer Janssen, which is a division of Johnson & Johnson, sought to expand its use to include patients with a common heart condition known as acute coronary syndrome (ACS), which occurs when blood flow to the heart is restricted because of blood clots that form in the heart arteries.
The company stands behind its drug and still hopes for a future approval. "We are confident in the robust study results of the ATLAS ACS ... trial and the positive benefit-risk profile of rivaroxaban in patients with ACS. We will continue to work with the FDA to fully address their questions as quickly as possible," said Paul Burton, MD, PhD, vice president, Cardiovascular Franchise Medical Leader at Janssen R&D.
More than 1 million people in the U.S. are hospitalized for heart attacks, strokes, and other events linked to ACS each year.
New-Generation Blood Thinners
Xarelto is one of three new drugs that have been eagerly awaited alternatives to the widely prescribed blood thinner warfarin (Coumadin, Jantoven, Marfarin).
Patients taking warfarin must be closely monitored because of the risk for brain hemorrhages and other potentially life-threatening bleeding events.
Pradaxa, marketed by global drug maker Boehringer Ingelheim, became the first of the new blood thinners to win FDA approval late in 2010, followed by Xarelto last summer.
Safety questions have still plagued both drugs since they entered the U.S. market.
In the months after Pradaxa was approved to lower stroke and blood clot risk in patients with atrial fibrillation, about 500 cases of hemorrhaging were reported, according to the nonprofit drug monitoring group Institute for Safe Medication Practices.
And in a surprise move late last month, an FDA panel set the stage for Thursday's action by voting 6 to 4 against recommending the approval of Xarelto to treat patients with ACS.
At the time, the panel cited concerns about bleeding risk and missing data from the pivotal ATLAS trial of the drug.
Missing Data Cited by Panel
In that trial, Xarelto was found to reduce the risk of death or stroke by 15% among patients recently hospitalized for acute coronary syndrome.
But panel members were concerned that the researchers had incomplete outcome data on 12% of the study participants.