FDA Approves First Pradaxa Reversal Agent

The FDA today has granted accelerated approval to Boehringer Ingelheim's intravenous solution idarucizumab (Praxbind) for the rapid reversal of Pradaxa.

The FDA today has granted accelerated approval to Boehringer Ingelheim’s intravenous solution idarucizumab (Praxbind) for the rapid reversal of the manufacturer’s anticoagulant, dabigatran (Pradaxa).

Praxbind is the first reversal agent approved specifically for Pradaxa, which was initially given the FDA’s nod in 2010 for the prevention of stroke and systemic blood clots in patients with atrial fibrillation, as well as for the treatment and prevention of deep venous thrombosis and pulmonary embolism.

The approval follows Boehringer Ingelheim’s submission of a biologics license application for Praxbind in March 2015. The agency ultimately based its decision on data in which the drug’s safety and efficacy were demonstrated in 283 healthy participants across 3 studies. In one trial, participants treated with Praxbind achieved complete anticoagulation reversal with a single 5-minute infusion, an effect that was maintained for more than 24 hours.

“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,” said Richard Pazdur, MD, director of the FDA’s Office of Hematology and Oncology Products, in a press release. “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 most common adverse events associated with the drug’s use included headache, hypokalemia, confusion, constipation, fever, and pneumonia. The Praxbind labeling recommends that patients resume their anticoagulant therapy as soon as medically appropriate, as reversing the effect of Pradaxa exposes patients to the risk of blood clots and stroke from their initial condition.

“Boehringer Ingelheim has a strong history of leadership in researching new ways to care for patients in the cardiovascular community,” stated Boehringer Ingelheim Senior Vice President Sabine Luik, MD. “With today’s FDA approval, we are tremendously proud to bring a new option to physicians and patients.”