June 22, 2015
By Mark Terry, BioSpace.com Breaking News Staff
Germany-based Boehringer Ingelheim announced today positive results from a Phase III RE-VERSE AD clinical trial. The study shows that 5 grams of idarucizumab almost immediately reversed the anticoagulant effect of dabigatran (Pradaxa) in patients who needed it under emergency situations.
Study results were also simultaneously published in The New England Journal of Medicine under the title, “Idarucizumab for Dabigatran Reversal.” The conclusion of the article was blunt: “Idarucizumab completely reversed the anticoagulant effect of dabigatran within minutes.”
Based on laboratory analysis of dilute thrombin time, sometimes also called ecarin clotting time, the median maximum percentage reversal of the anticoagulant effect within 4 hours was 100 percent.
In an editorial written by Kenneth Bauer, a physician with Beth Israel Deaconess Medical Center in Boston, he said, “With the growing use of direct oral anticoagulants, it would be advantageous to have reversal agents that can rapidly and completely neutralize the anticoagulant activity of the drug and restore normal hemostasis…. Given that there are no established reversal strategies for the direct oral anticoagulants, it is appropriate to undertake clinical trials of these agents without a control group.”
He goes on to say, however, “Without a control group, it is difficult to assess the clinical benefit that is conferred by the administration of idarucizumab in patients with dabigatran-related bleeding.”
Noting that antidotes to neutralize various oral anticoagulants rapidly is “an important advance,” Bauer nonetheless says that “Additional studies, however, will be required to determine in which situations the antidotes improve clinical outcomes.”
The study was designed to look at different types of patients and real-world situations healthcare providers may see in emergency situations. Patients were split into two groups. The first group was patients with uncontrolled or life-threatening bleeding complications like intracranial hemorrhage or severe trauma after a car accident, and the second was patients needing emergency surgery or an invasive procedure.
“The interim analysis from RE-VERSE AD is important for healthcare professionals as it provides the first insights into the effect of a specific reversal agent to a non-vitamin K antagonist oral anticoagulant during real-world emergency situations,” said Charles Pollack, professor of emergency medicine at the Perelman School of Medicine, University of Pennsylvania in Philadelphia, and lead investigator of the study, in a statement.
“As observed in earlier research in volunteers, idarucizumab reversed the anticoagulant effect of dabigatran in patients completely within minutes, even in those rare critical care situations studied in RE-VERSE AD. These data demonstrate the use of idarucizumab can help physicians focus on other vital aspects of emergency management beyond anticoagulant reversal in dabigatran-treated patients.”
The data is also being presented today at the International Society of Thrombosis and Haemostasis 2015 Congress in Toronto, Canada.
As Rumors Swirl About GlaxoSmithKline Bid, Who Could Suitors Be?
Rumors are swirling that Swiss-based Roche and U.S.-based Johnson & Johnson are eying the U.K. company for approximately $143 billion. But Roche and J&J aren’t the only companies though who have been thought could go after the elephant that is Glaxo.
Last month there was buzz that Pfizer Inc. was considering acquiring Glaxo, a year after it failed to acquire AstraZeneca PLC . Just this month over a third of respondents in a poll conducted by BioSpace believe that AstraZeneca PLC could be in the running to acquire struggling GlaxoSmithKline (GSK).
So BioSpace wants to ask our readers again what they predict for this new dealmaking bonanza. Will Glaxo go—and if so, to whom?
