Bristol-Myers, Pfizer's Eliquis approved in Japan
Regulators in Japan have approved sales of an anticlotting drug called Eliquis, developed by Bristol-Myers Squibb Co. and Pfizer Inc., that's a potential blockbuster in a new category of medicines to prevent strokes and heart attacks. But that's only if it can win U.S. approval, as two rival drugs have done.
Pfizer and Bristol-Myers said Wednesday that Japan approved use of Eliquis for treating the most common type of irregular heartbeat, atrial fibrillation, in patients at risk for strokes or dangerous clots called systemic embolisms. Already approved for sale in Canada and the European Union, Eliquis has twice been rejected by the U.S. Food and Drug Administration.
About a quarter of all people aged 40 and older develop atrial fibrillation, a condition in which the heart's two upper chambers contract irregularly and don't pump blood efficiently. This can persist for years or only happen occasionally. It increases the risk of a stroke fivefold, and strokes caused by atrial fibrillation are more severe than other strokes, with half of patients who suffer them dying within a year if not treated.
For decades, atrial fibrillation patients were treated with the blood thinner warfarin, sold under brands including Coumadin. While warfarin is very cheap, users must get frequent blood tests to ensure they're getting enough to prevent strokes but not too high a dose, which can cause dangerous internal bleeding.
In the last two years, drug regulators in the U.S. and other countries have approved two new anticlotting drugs for patients with atrial fibrillation and other conditions: Pradaxa, from German drugmaker Boehringer Ingelheim, and Xarelto, from partners Johnson & Johnson and Bayer Healthcare.
Some analysts have said Eliquis, known chemically as apixaban, is the best of the three new drugs, but Pradaxa and Xarelto got a big head start in building U.S. market share. That means that if Eliquis is approved by the FDA, Pfizer and Bristol-Myers will have a tough job persuading doctors and patients who already have switched from warfarin to Pradaxa or Xarelto to again switch medication.
The FDA originally was to decide whether to approve Eliquis last March, but said it needed more time to review new data. In June, the FDA said it couldn't approve the drug until the companies provided more information on "data management and verification" from a huge international study called ARISTOTLE. That was submitted in September. The FDA is scheduled to rule by March 17.
Approval in Japan, the world's second-biggest market for prescription drugs after the U.S., will boost sales of Eliquis, but U.S. sales are needed to reach blockbuster status—annual sales of more than $1 billion.
The makers of all three drugs must persuade doctors and consumers that their pill is the most effective and safest, and that it's worth the extra cost. Xarelto and Pradaxa both cost roughly $250 per month. Pfizer and Bristol-Myers have not disclosed a price for Eliquis. Warfarin typically costs less than $10 per month, plus at least $1,600 a year for frequent tests of its level in the blood.
Johnson & Johnson has not has not yet reported sales figures for Xarelto. However, partner Bayer reported Xarelto sales totaling about $235 million in the first nine months of this year. Boehringer Ingelheim reported Pradaxa sales of about $615 million worldwide in the first half of 2012.
In afternoon trading, shares of Bristol-Myers were down 12 cents at $32.34, and Pfizer shares were up 11 cents at $25.19.
Copyright 2012 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed.
- Bristol-Pfizer anticlot drug gets key EU approval Nov 20, 2012 | not rated yet | 0
- Anti-clot drug recommended for new approval in EU Sep 21, 2012 | not rated yet | 0
- FDA adds new heart warning to Sanofi's Multaq Dec 19, 2011 | not rated yet | 0
- J&J wins US approval for new blood thinner Jul 02, 2011 | not rated yet | 0
- FDA: Pradaxa not for patients with mechanical heart valves Dec 21, 2012 | not rated yet | 0
- Motion perception revisited: High Phi effect challenges established motion perception assumptions Apr 23, 2013 | 3 / 5 (2) | 2
- Anything you can do I can do better: Neuromolecular foundations of the superiority illusion (Update) Apr 02, 2013 | 4.5 / 5 (11) | 5
- The visual system as economist: Neural resource allocation in visual adaptation Mar 30, 2013 | 5 / 5 (2) | 9
- Separate lives: Neuronal and organismal lifespans decoupled Mar 27, 2013 | 4.9 / 5 (8) | 0
- Sizing things up: The evolutionary neurobiology of scale invariance Feb 28, 2013 | 4.8 / 5 (10) | 14
Pressure-volume curve: Elastic Recoil Pressure don't make sense
11 hours ago From pressure-volume curve of the lung and chest wall (attached photo), I don't understand why would the elastic recoil pressure of the lung is...
If you became brain-dead, would you want them to pull the plug?
May 17, 2013 I'd want the rest of me to stay alive. Sure it's a lousy way to live but it beats being all-the-way dead. Maybe if I make it 20 years they'll...
MRI bill question
May 15, 2013 Dear PFers, The hospital gave us a $12k bill for one MRI (head with contrast). The people I talked to at the hospital tell me that they do not...
Ratio of Hydrogen of Oxygen in Dessicated Animal Protein
May 13, 2013 As an experiment, for the past few months I've been consuming at least one portion of Jell-O or unflavored Knox gelatin per day. I'm 64, in very...
Alcohol and acetaminophen
May 13, 2013 Edit: sorry for the typo in the title , can't edit I looked around on google quite a bit and it's very hard to find precise information on the...
Marie Curie's leukemia
May 13, 2013 Does anyone know what might be the cause of Marie Curie's cancer
- More from Physics Forums - Medical Sciences
More news stories
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.
Medications May 17, 2013 | not rated yet | 0
Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...
Medications May 17, 2013 | not rated yet | 0
(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...
Medications May 16, 2013 | 3.5 / 5 (2) | 0 |
(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...
Medications May 15, 2013 | not rated yet | 0
An increasing number of U.S. children are experiencing gastrointestinal issues that require interventions to resolve, according to research presented at Digestive Disease Week (DDW).
4 hours ago | not rated yet | 0 |
The latest makeover to a massive psychiatric tome honored by some, reviled by others and even called the "Bible" of mental disorders is being released Saturday with a host of new changes.
1 hour ago | not rated yet | 0
A new case of the deadly coronavirus has been detected in Saudi Arabia where 15 people have already died after contracting it, the health ministry announced on Saturday on its Internet website.
2 hours ago | not rated yet | 0
Big names in medicine are set to give an upbeat assessment of the war on AIDS on Tuesday, 30 years after French researchers identified the virus that causes the disease.
12 hours ago | 5 / 5 (1) | 0
For combat veterans suffering from post-traumatic stress disorder, 'fear circuitry' in the brain never rests
Chronic trauma can inflict lasting damage to brain regions associated with fear and anxiety. Previous imaging studies of people with post-traumatic stress disorder, or PTSD, have shown that these brain regions can over-or ...
13 hours ago | 5 / 5 (1) | 0 |
A ground-breaking advance in colonoscopy technology signals the future of colorectal care, according to research presented today at Digestive Disease Week(DDW). Additional research focuses on optimizing the minimal withdrawal ...
4 hours ago | 5 / 5 (1) | 0