Pharmaceutical company Boehringer Ingelheim revealed on Tuesday the receipt of the US Food and Drug Administration (FDA) full approval for Praxbind (idarucizumab) indicated in patients treated with Pradaxa when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures or in life-threatening or uncontrolled bleeding.
The German company said the US FDA granted accelerated approval to Praxbind in October 2015, with continued approval contingent upon results from the phase III RE-VERSE AD trial, the largest study to investigate a reversal agent for a NOAC. The study investigated a reversal agent for a novel oral anticoagulant (NOAC) in real-world emergency settings. It enrolled a total of 503 patients at 173 sites in 39 countries, which were included in one of two group.
In conjunction, the final results of the company's RE-VERSE AD were published in the New England Journal of Medicine in July 2017 and showed that Praxbind immediately reversed the anticoagulant effect of Pradaxa. In clinical studies, Praxbind has not shown a procoagulant effect.
According to the company, Praxbind is stocked in more than 3,000 hospitals in all 50 states nationwide. Healthcare providers and patients can quickly search for institutions in the US where Praxbind is stocked by using a zip code locator tool available at Praxbind.com.
Additionally, Praxbind is distributed by US.hospital pharmacy distributors ASD, Cardinal Health, MPB, HD Smith and Morris Dickson. Orders can generally be filled or restocked within 24 hours, concluded the company.
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