Praxbind Receives Full FDA Approval
April 12, 2018 – The U.S. FDA has granted full approval to Praxbind® (idarucizumab), manufactured by Boehringer Ingelheim. The drug is indicated to reverse the anticoagulant effects of Boehringer Ingelheim’s Pradaxa® (dabigatran etexilate) when emergency surgery or urgent procedures are required, or in the event of uncontrolled or life-threatening bleeding.
The FDA originally granted Praxbind accelerated approval in 2015. Full approval was based on the completion of an additional study that demonstrated the drug’s immediate effect. In clinical trials, Praxbind began to reverse the anticoagulant effects of Pradaxa as soon as administered, and achieved complete reversal of these effects within four hours for most patients.
Recommended dosing is via intravenous infusion in either two separate doses of 2.5g or one single 5g dose. Because Praxbind is typically used in the event of emergency, it is kept on hand at a network of hospitals across the United States. Boehringer Ingelheim provides a locator tool on the drug’s website.
Praxbind is currently the only FDA-approved specific reversal agent for a novel oral anticoagulant (NOAC).
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- U.S. Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
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*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.