In a major development for Boehringer Ingelheim, the company announced that their anticoagulant stopping agent for internal bleeding is officially on the FDA’s fast-track approval process.

Over the past year, the German pharmaceutical company has been perfecting a stopping agent for their product, Pradaxa, which has been linked to over 500 deaths from uncontrollable internal bleeding.

Previously, Boehringer Ingelheim’s stopping agent had been granted “breakthrough” status after pre-clinical trials indicated positive results with Pradaxa. Now with idarucizumab approved for the next stage of the process, it is expected that it will officially be ready for market four months earlier than initially predicted.

At this rate, Boehrigner Ingelheim will be the first company to have a stopping agent available for their anticoagulant, in order to prevent internal bleeding injuries. This came as a surprise to many in the medical community, because Boehringer’s anticoagulant competition had been developing their own bleeding antidotes.

Portola Pharmaceuticals has been collaborating with Pfizer, Bristol-Myers, Janssen Pharmaceuticals, and Bayer Pharmaceuticals, to develop a bleeding antidote for Eliquis and Xarelto.

Even though Boehringer Ingelheim beat its competitors to the punch, medical experts state that it could also be beneficial to Xarelto and Eliquis because the FDA is likely to have an optimistic outlook for similar proposals.

For now though, Boehringer has been granted Priority Review to the Biologics License Application (BLA) for idarucizumab, which is expected to cut down the approval process significantly. Idarucizumab will be reviewed under Accelerated Approval, and is the first reversal agent for the new generation anticoagulants.

Interestingly enough, Boehringer Ingelheim had been the first company to break into the lucrative anticoagulant market; Pradaxa was the first drug of this kind on the market since the approval of Warfarin in 1952.

For decades, Warfarin had been the only treatment option for patients with atrial fibrillation and other clotting disorders. When Pradaxa came out in 2010, many patients were relieved at the new treatment option, and were thrilled to learn that they did not need constant dose adjustment and medical monitoring.

Overview of New Generation Anticoagulant Bleeding Risks

After seeing Boehringer Ingelheim glow in success, other pharmaceutical companies jumped on the anticoagulant bandwagon.

In 2011, Xarelto was released onto the market as a joint effort between Bayer Pharmaceuticals and Johnson & Johnson’s subsidiary, Janssen Pharmaceuticals. Despite Pradaxa’s success on the market, Xarelto dominated the anticoagulant market repeatedly, due to Jansen and Bayer’s aggressive marketing.

Most recently, Eliquis was released in 2012 as another joint effort between pharmaceutical companies Pfizer Inc. and Bristol-Myers.

However, medical experts soon noticed that the new-generation anticoagulants lacked major safety features that Warfarin came with. Unlike Pradaxa and the newer anticoagulants, Wafarin had an established and approved stopping agent in the form of vitamin K, which could be applied in the cases of uncontrollable internal bleeding.

Additionally, Warfarin required frequent dose adjustments and doctor appointments of patients, to insure they were using the drug safely and to determine what dosage amount would be best.

Not to say that Pradaxa and other new anticoagulant patients did not follow prescription instructions, they simply did not have the same safety nets in place. As stated in many articles, the new generation anticoagulants do not have a bleeding antidote, requiring hospital intervention in the case of bleeding injuries. However, the newer blood-thinners advertise that they came in one constant dosage to patients and do not require frequent doctor visits, making their convenience very attractive.

Many experts believe that if the new generation anticoagulants had been subjected to frequent doctor visits like Warfarin, then many bleeding incidents would have been prevented, even without a bleeding antidote. It remains to be seen how successful Boehringer Ingelheim’s bleeding antidote will be, but experts predict that the outcome will most likely be positive reception.