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FDA approves Boehringer’s Pradaxa reversal agent

Published on 19/10/15 at 09:58am
BI building at night

The FDA has approved Boehringer Ingelheim’s Praxbind, a reversal agent for its anticoagulant Pradaxa.

The US regulator approved Praxbind (idarucizumab) for use when reversal of the anticoagulant effect of dabigatran is needed for emergency surgery or uncontrolled bleeding.

Pradaxa (dabigatran etexilate) was the first in a new class of anticoagulants to be approved, and is now marketed in over 100 countries as offering comparable blood-thinning effects to warfarin without the need for ongoing monitoring.

While the blood thinner was approved in the US in 2010, safety concerns remain over Pradaxa’s potential to cause severe or fatal bleeding. Boehringer believes the FDA green light for the Praxbind reversal agent will help alleviate concerns and increase confidence in the prescription of Pradaxa.

Speaking to Pharmafile in June, Boehringer bosses said the availability of an effective antidote could offer BI an advantage in a class of drugs still suffering a negative perception of bleeding risk.

Professor Jörg Kreuzer, vice president of medicine and the therapeutic Area Cardiovascular, Boehringer Ingelheim, comments: "While we anticipate that Praxbind will be rarely used in clinical practice, the availability of a specific reversal agent has the potential to give physicians and patients added confidence in choosing Pradaxa."

Richard Pazdur, director of the office of hematology and oncology products in the FDA’s Center for Drug Evaluation and Research, says: “The anticoagulant effects of Pradaxa are important and life-saving for some patients, but there are situations where reversal of the drug’s effects is medically necessary. Today’s approval offers the medical community an important tool for managing patients taking Pradaxa in emergency or life-threatening situations when bleeding can’t be controlled.”

The safety and effectiveness of Praxbind were studied in three trials involving a total of 283 healthy volunteers taking Pradaxa, who did not require an anticoagulant, while a further trial tested the treatment in 123 patients who did require the drug due to severe bleeding or the need for emergency surgery. In the studies, the reversal effects of Praxbind were evident immediately.

The FDA granted Praxbind Breakthrough Therapy gesignation and the application received priority review. Praxbind was approved under an accelerated approval pathway. It is currently being assessed by several regulatory authorities, including Health Canada, and further submissions are ongoing.

Joel Levy

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