Boehringer Ingelheim submitted U.S., European and Canadian applications for an antidote to its own Pradaxa, leading the way among companies developing treatments that reverse the effects of blockbuster next-generation anticoagulants.
The drug, which secured the FDA's breakthrough-therapy designation, is an antibody fragment 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 Jörg 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.
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