Boehringer wins FDA OK for Pradaxa antidote, eyes bigger market share

Boehringer Ingelheim picked up an FDA nod for an injection designed to reverse the effects of its blockbuster anticoagulant Pradaxa, marking the first approval for an antidote to a next-generation blood thinner.

The treatment, to be sold as Praxbind, is an antibody fragment designed to reverse the anticoagulant effects of Pradaxa, which prevents clotting by blocking the enzyme thrombin. In three late-stage trials, the intravenous therapy charted an immediate, complete and sustained interruption of Pradaxa's mechanism of action within 24 hours, Boehringer said. The most common side effects with Praxbind were headache and low potassium, according to the FDA.

The approval could give Pradaxa a leg up over its rivals, led by Bayer and Johnson & Johnson's ($JNJ) Xarelto as well as Bristol Myers-Squibb ($BMY) and Pfizer's ($PFE) Eliquis. Portola Pharmaceuticals ($PTLA) is at work on an antidote to those therapies but doesn't expect to file it for FDA clearance until later this year.

For now, Pradaxa is the only antithrombin treatment with an approved reversal agent, giving Boehringer a chance to improve on the roughly $1.7 billion in annual revenue it gets from the drug.

In September, Praxbind secured a positive opinion from the European Medicines Agency's Committee for Medicinal Products for Human Use, a milestone generally followed by full approval within three months.

Meanwhile, Boehringer has long maintained 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.

- read the statement

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