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 Related Stories
- Developers evict historic women's shelter to build luxury hotel
- Kaitlyn Hunt refuses plea offer, will go to court over high school relationship
- DHS admits "impossible" to control 3D-printed guns
- Journalists file suit against Manning trial secrecy
- Russia: Syrian regime ready to talk peace
- Report: Nearly a quarter of all Americans struggle to afford food
- Ted Cruz against the world
- Louie Gohmert: Women should be forced to carry nonviable pregnancies to term
- 2 men arrested for endangering commercial aircraft
- Oversized load blamed for bridge collapse
- This is what Guy Fieri looks like as a balloon
- Iran hackers aiming at U.S. energy firms
- Lawyers release data in attempt to discredit Trayvon Martin
- Anonymous rallies behind Kaitlyn Hunt
- Bridge collapse: Part of "aging infrastructure"
- Mistrial in penalty phase of Arias case
- Amanda Bynes arrested after hurling bong from window
- Interstate 5 bridge collapses north of Seattle
- Mississippi could begin prosecuting women for miscarriages
- Teenage girl claims she was beaten up for looking like Taylor Swift
- UK Military: London attack victim was a "model soldier"
Featured Slide Shows
The week in 10 picsclose X
- 1 of 11
Credit: AP/LM Otero
Credit: AP/Matt Rourke
Credit: AP/Jenny Aicher
Credit: AP/Molly Riley
Credit: AP/J. Scott Applewhite
Credit: AP/Carolyn Kaster
Credit: AP/Las Vegas Review-Journal/Jeff Scheid
Credit: AP/NASA/Chris Hadfield
Credit: AP/Jacquelyn Martin
Credit: AP/The Duluth News-Tribune/Clint Austin
Recent Slide Shows
- 1 of 11