Europe blesses Pradaxa for stroke prevention

It's official: Boehringer Ingelheim has the European OK to sell its blood thinner Pradaxa as a stroke-prevention treatment in atrial fibrillation patients. The German company has beat rivals to the punch several times now, first with European approval to prevent blood clots in patients who've had joint replacement surgery, second with a stroke-prevention OK in the U.S. And now, the new EU use. Analysts are saying that Pradaxa will hit $1.3 billion on stroke-prevention alone.

The question now is whether the first-to-market advantage will end up holding when and if Bayer and Johnson & Johnson can sell Xarelto for the same use--and particularly when Bristol-Myers Squibb and Pfizer's yet-to-be-approved Eliquis (a.k.a. apixaban) hits. All three drugs are replacements for the clot-prevention standby warfarin, which has complicated dosing.

In June, Bristol and Pfizer announced new data showing that Eliquis was better and much safer than warfarin at preventing strokes in AF patients, making it a potentially formidable rival for Pradaxa (and Xarelto, for that matter). The companies say they're planning to file for that approval later this year. The stroke-prevention market is expected to grow to $14 billion by 2017, so these drugs could be very big earners.

- read the Boehringer release
- get more from Reuters
- see the Dow Jones story

Suggested Articles

Pfizer will exit its Perth, Australia sterile injectables manufacturing site by 2024 as part of a global production reorganization effort.

Agios has withdrawn a European application for Tibsovo in AML after the same phase 1 data that earned it an FDA nod failed to impress the EMA.

Sanofi is reportedly considering a sale of some of its anti-inflammation drugs that could snare $234 million as the company pivots toward Dupixent.