FDA sends J&J CRL on Xarelto for stent thrombosis

The FDA keeps offering up tough news to Johnson & Johnson ($JNJ) for its warfarin replacement, Xarelto. It has twice turned it down for treatment of acute coronary syndrome (ACS), and today the company said it had a complete response letter for use of the bloodthinner to prevent stent thrombosis in patients with ACS.

Dr. Christopher Nessel, vice president, cardiovascular franchise medical leader at J&J's Janssen Research & Development, tried to put a good face on the news. "We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are in ongoing discussions with the FDA regarding this sNDA," he said. The company pointed out that Xarelto is already approved in the U.S. for 6 conditions and said it is the most prescribed of the new oral anticoagulants in the U.S. market.  

As The Wall Street Journal points out, coronary stents are implanted in more than 1.5 million patients each year. Patients take bloodthinners to prevent stent thrombosis, which occurs when blood pools around the stent. If that happens, it can mean a potentially fatal heart attack. 

The bloodthinner is approved for treating atrial fibrillation, which is a big market, but J&J and its partner Bayer AG have been hoping for a much wider use of the drug. There are 1.2 million ACS patients sent to the hospital each year, so approval for treating it would be a big deal. The FDA initially asked for more data, including on bleeding risks, but in March it said that what it was given still fell short of what it needs to allay concerns.

Xarelto is one of several drugs that have come on the market to challenge warfarin, which has been the standard treatment for years but which comes with its own troubling side effects. EvaluatePharma's new World Preview report predicts the market for anticoagulant drugs will grow 11.5% annually through 2018 and reach $15.3 billion in sales, up from about $8 billion. Pradaxa from Boehringer Ingelheim was the first warfarin alternative to market and has provided tough competition for Xarelto. Pfizer ($PFE) and Bristol-Myers Squibb's ($BMY) have their new entry, Eliquis, but it has not done as well as they expected.  In the last quarter, J&J reported sales of $158 million for Xarelto, up from just $27 million in the same quarter a year ago. It said the strong sales helped offset falling sales of other drugs. Bayer has indicated it expects the drug to hit peak sales of $2.5 billion.

To get there, J&J and Bayer keep looking for more approvals for the drug. In March said they will test the pill in a Phase III trial on patients with chronic heart failure and significant coronary artery disease. They have said it is the first of the new anticoagulants to be evaluated for this patient group and point out that heart failure is a big problem worldwide. Last fall, the anticoagulant won European approval to treat and prevent pulmonary embolism and to prevent deep vein thrombosis and was the the first warfarin-alternative drug to win those indications.

- here's the J&J release
- get more from The Wall Street Journal