|FiercePharma file photo|
Looks like the FDA has taken an advisory committee's Xarelto concerns to heart. Following up on an overwhelming "no" vote from last month, the agency Friday issued Johnson & Johnson's ($JNJ) Janssen unit complete response letters regarding use of the anticoagulant in acute coronary syndrome (ACS) patients.
The letters come in the wake of a 10-0 panel vote to reject the drug for that treatment, during which experts questioned whether data from Xarelto's only clinical trial, the ATLAS program, were a strong enough basis for approval--especially considering that some of the trial data were missing. It's the third rejection for the blood thinner in patients with ACS, a complication of coronary heart disease, the leading cause of death in the U.S.
Paul Burton, Janssen's VP of clinical development, said in a statement that the company was evaluating the contents of the letters and would determine the appropriate next steps. "We remain committed to providing patients who have suffered from acute coronary syndrome with additional protection against stent thrombosis and secondary life-threatening cardiovascular events," he said.
One in a new class of warfarin replacement therapies, Xarelto has been racking up the indications since it first hit the market. It's currently approved for 6 uses, including preventing stroke in atrial fibrillation patients, a big market that put it in a head-to-head showdown with rival drug Pradaxa from Boehringer Ingelheim. But the ACS indication would have been even bigger, with 1.2 million patients hospitalized annually.
While this may be Xarelto's third strikeout, following FDA rejections in June 2012 and March of last year, Janssen can take comfort in the fact that its drug is so far the only one in its generation--which also includes Eliquis from Pfizer ($PFE) and Bristol-Myers Squibb ($BMY)--to generate data strong enough to warrant an sNDA. Sales haven't exactly been scarce, either: One of FiercePharma's Top 15 Drug Launch Superstars in 2013, Xarelto pulled in $347 million in U.S. sales in the first half of last year, netting an additional €374 million ($513 million) for partner Bayer outside the U.S.
- read the release
Special Report: Top 15 Drug Launch Superstars - Xarelto - Bayer and Johnson & Johnson