Boehringer ingelham submits pradaxa adjuvant application

March 4, 2015 / BIOON / - in the process of biomedical research and development, researchers are most concerned about whether the efficacy of this drug is significant, but the so-called too much, some drugs are too significant, which will always bring sweet sadness to patients and biomedical companies And bringer Ingelheim has a deep understanding of this Pradaxa, a new generation anticoagulant developed by the company, has been favored by FDA and granted breakthrough drug therapy certification before it goes on the market due to its excellent efficacy Pradaxa is an antibody fragment drug that blocks thrombin to achieve anticoagulant effect However, experts in the examination and approval found that pradaxa's excellent efficacy is likely to exceed the doctor's control, resulting in the failure of blood coagulation in time and even endangering the life of patients It wasn't until then that Brigitte Ingelheim's staff realized that sometimes it wasn't a good thing to get too good results In order to overcome this side effect of pradoxa, bringer Ingelheim developed an auxiliary drug, idarucizumab, which can stop the anticoagulant effect of pradoxa by blocking the interaction between pradoxa and thrombin At present, the company has submitted applications to the pharmaceutical management departments in the United States, Canada and Europe Bringer Ingelheim has always been a leader in the anticoagulant market Pradaxa is its new generation of anticoagulant drug At present, the annual sales of this drug has reached 1.7 billion US dollars, next to xarelto of Johnson and Bayer, eliquis of Squibb and Pfizer Once idarucizumab is approved to go public, pradaxa will gain more market share At the same time, it will also ease the pressure of legal disputes faced by the company Last year, the company paid $650 million to settle more than 4000 lawsuits related to the side effects of blood clotting drugs Detailed English report: Boehringer Ingelheim submitted U.S., European and Canadian applications for an antiote to its own pradaxa, leading the way along companies developing treatments that reverse the effects of blockbuster next generation anticoagulants designed to reverse the anticoagulant effects of Pradaxa, which prevents clotting by blocking the enzyme thrombin Dubbed idarucizumab, Boehringer's reversal agent did just that in clinical trials, the company said, charting an immediate, complete and sustained interruption of Pradaxa's mechanism of action With the filings, Boehringer leads its top rival in the space, Portola Pharmaceuticals ($PTLA), which is working up an antidote to a wide swath of new anticoagulants The company has a breakthrough tag of its own for andexanet alfa, designed to counteract Bayer and Johnson & Johnson's ($JNJ) Xarelto as well as Bristol Myers-Squibb ($BMY) and Pfizer's ($PFE) Eliquis Portola just wrapped up its Phase III program and expects to file andexanet alfa for FDA approval by the end of 2015 With its first-mover status, Boehringer hopes to boost Pradaxa's profile a competitive field The drug currently lags its Xarelto and Eliquis, pulling in about $1.7 billion a year, but, if the FDA approves idarucizumab, it'll be the only new anticoagulant with an on-the-market antidote, likely a boon to sales "The submissions for idarucizumab mark the first regulatory submissions for a specific reversal agent to a novel oral anticoagulant," Boehringer Vice President J?rg Kreuzer said in a statement "Our discovery and development of idarucizumab in-house is an example of our company's dedication to the evolution and innovation of anticoagulation care." Meanwhile, Boehringer is quick to note that the development of an antidote in no way undermines its faith in Pradaxa's safety Last year, the company agreed to pay about $650 million to settle more than 4,000 lawsuits tied to the blood thinner, a move that came just months after the FDA reviewed data on the drug and concluded that, when used as directed, it's as safe as warfarin