SALON

Friday, Sep 7, 2012 6:30 PM UTC

J&J again seeks more approvals for clot blocker

By

Topics: From the Wires,

TRENTON, N.J. (AP) — Johnson & Johnson said Friday that it has given the Food and Drug Administration additional data on its new anticlotting drug, in a second attempt to get approval for more uses.

Xarelto already is approved for three uses: for reducing risk of blood clots in people who’ve had knee replacement surgery or hip replacement surgery and for reducing stroke risk in people with a common irregular heart rhythm, atrial fibrillation, not caused by a heart valve problem.

It’s part of a new generation of blood thinners seen as big money makers by analysts and the pharmaceutical industry, and viewed by doctors and patients as possible improvements over the long-time standard, warfarin. Warfarin, sold under brands including Coumadin, is inexpensive but requires frequent blood tests to get the dosage right to prevent dangerous internal bleeding.

J&J has been seeking approval to market Xarelto for preventing a second heart attack or stroke in patients at high risk because of a narrowed heart artery, and for preventing blood clots from forming around stents, tiny metal-mesh scaffolds that prop open heart arteries after they have been unblocked.

The FDA turned down the company’s application for the first use in June. That was shortly after agency advisers expressed concerns about bleeding side effects in some study patients and said they didn’t have enough information to accurately gauge the benefits of Xarelto. J&J withdrew the other application a few weeks later.

The company, based in New Brunswick, N.J., said Friday that it has sent the FDA data from a huge study showing Xarelto, a twice-daily pill known chemically as rivaroxaban, prevented strokes, heart attacks and deaths.

The 15,526-patient study found that adding Xarelto to a low-dose aspirin and a second standard drug reduced those cardiac risks by an additional one-sixth to one-third. The study, called ATLAS, was completed last year.

Johnson & Johnson so far has not reported any sales figures for Xarelto, but said in July that it was among several new products posting strong sales in the second quarter. The company markets Xarelto jointly with Bayer Healthcare.

Xarelto competes with Boehringer Ingelheim’s Pradaxa, which was approved for U.S. sales in late 2010.

Both drugs are very pricey compared to the typical 50 cent-per-day cost of warfarin. Pradaxa costs more than $130 per month and Xarelto more than $250 per month.

Their makers are striving to get more patients on those two drugs before the likely arrival of a third competitor that some analysts have said appears to work better: Eliquis. That drug, developed by partners Bristol-Myers Squibb Co. and Pfizer Inc., was rejected in June by the FDA. The agency is requiring additional information on Eliquis before it will again consider approval.

More Linda A. Johnson.

Next Article

Related Stories

More Related Stories

Featured Slide Shows

The week in 10 pics

close X
  • Share on Twitter
  • Share on Facebook
  • Thumbnails
  • Fullscreen
  • 1 of 11
  • Lisa Montgomery embraces her nephew Thursday after a tornado tore apart her home in Cleburne, Texas. The twister killed six people and destroyed entire swaths of the North Texas town.
    Credit: AP/LM Otero

  • Jack McMahon, the defense attorney for abortion doctor Kermit Gosnell, speaks outside the Criminal Justice Center in Philadelphia Tuesday. His client was convicted of killing three babies in his clinic, and will serve multiple life sentences.
    Credit: AP/Matt Rourke

  • A photo taken Monday captures Vice President Joe Biden's response to a Milwaukee second-grader's innovative proposal to end America's epidemic of gun violence. This guy!
    Credit: AP/Jenny Aicher

  • Sen. Rand Paul, R-Ky., flanked by a grouper-eyed Michele Bachmann, addresses the IRS' admission that it targeted Tea Party groups in advance of the 2012 election. In an op-ed for CNN Thursday, the Kentucky senator slammed the president for his faux outrage.
    Credit: AP/Molly Riley

  • Ousted IRS chief Steven Miller is sworn in on Capitol Hill Friday. Miller testified before the House Ways and Means Committee on the extra scrutiny the agency gave conservative groups applying for tax-exempt status.
    Credit: AP/J. Scott Applewhite

  • Attorney General Eric Holder pauses as he testifies on Capitol Hill before the House Judiciary Committee Wednesday. Holder is under fire, among other things, for the Justice Department's gathering of phone records at the Associated Press.
    Credit: AP/Carolyn Kaster

  • O.J. Simpson sits during an evidentiary hearing at Clark County District Court in Las Vegas, Nev., Thursday. Simpson, who is currently serving a nine-to-33-year sentence in state prison for armed robbery and kidnapping, is using a writ of habeas corpus to seek a new trial.
    Credit: AP/Las Vegas Review-Journal/Jeff Scheid

  • Major Tom to ground control: On Sunday astronaut Chris Hadfield recorded the first music video from space, a cover of David Bowie's "Space Oddity."
    Credit: AP/NASA/Chris Hadfield

  • When it rains it pours. President Barack Obama speaks during a news conference Thursday with Turkish Prime Minister Recep Tayyip Erdogan, inexplicably inspiring an #umbrellagate Twitter meme.
    Credit: AP/Jacquelyn Martin

  • A smoke plume rises high above a road block at the intersection of County A and Ross Road east of Solon Springs, Wis., Tuesday. No injuries were reported, but the the wildfire caused evacuations across northwestern Wisconsin.
    Credit: AP/The Duluth News-Tribune/Clint Austin

  • Recent Slide Shows

  • Share on Twitter
  • Share on Facebook
  • Thumbnails
  • Fullscreen
  • 1 of 11

Related Videos

Comments

 0 Comments

Comment Preview

Your name will appear as username

You may use these HTML tags and attributes: <a href=""> <b> <em> <strong> <i> <blockquote>

follow salon

Most Read

Popular on Reddit

links from salon.com

From Around the Web

Presented by Scribol
listener_new_rect The Listener: Chekhov's story mirrors Russia's own

Recommendations