Pradaxa, from Boehringer Ingelheim, was approved by the Food and Drug Administration last October.
The most likely outcome: Pradaxa gets approved at both doses, but with a weak label.
The letter will inform physicians that Pradaxa is now contraindicated in patients with mechanical heart valves.
FORBES: Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves
Before Pradaxa was approved, advertisements were running on TV telling patients to ask their doctors about atrial fibrillation.
Boehringer Ingelheim is starting to inform physicians about a new contraindication for its oral anticoagulant drug Pradaxa (dabigatran).
FORBES: Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves
This could force Boehringer to market Pradaxa as equivalent to warfarin, not better.
Our model assumes Xarelto captures 31% of sales among new anticoagulants in 2015 with Eliquis capturing 45% and Pradaxa only 18%.
Pfizer and partner Bristol-Myers Squibb Co. will promote it jointly, noting its advantages over two rival drugs on the market already, Xarelto and Pradaxa.
Pradaxa is being marketed to consumers via television and print advertisements.
It is way behind drugs like Pradaxa (already approved) and Xarelto (probably coming soon) but Merck argues it has the potential to be best in class.
Xarelto is once-a-day (good), Pradaxa causes some stomach upset (bad).
We are not making any changes to our anticoagulant market model because we reduced our Xarelto and Pradaxa share assumptions when the top-line data from ARISTOTLE were released this past June.
Next year, you should expect to hear a lot about Pradaxa and Xarelto, especially if you watch the evening news, CNN, or other television shows that are supported by pharmaceutical advertising.
But in the narrower atrial fibrillation market, which is where Pradaxa is already approved, it is being used 16% of the time, says Mark Schoenebaum, a health care analyst at stock research firm ISI Group.
Although it seemed to outperform warfarin, the design of the trial (doctors and patients knew who was on warfarin and who was getting Pradaxa) weakens that conclusion, and the FDA did not allow a superiority claim.
The FDA action follows a similar decision by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency, which announced last week that it had recommended that Pradaxa be contraindicated in patients with prosthetic heart valves.
FORBES: Pradaxa To Be Contraindicated In Patients With Mechanical Heart Valves
With Pradaxa, which is already on the market, the advertising has already begun, with an awareness campaign by Susan Lucci (her husband as a fib) that started before the drug was approved. (Companies are allowed to raise awareness about disease before they can market their own drugs.) With competition approaching, Pradaxa maker Boerhinger Ingelheim has no choice but to get the word out fast.
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