AMAG Announces Presentation of Ciraparantag Data at the International Society on Thrombosis and Haemostasis

Nachrichtenquelle: globenewswire
12.07.2020, 14:30  |  141   |   |   

Data from two Phase 2 randomized, placebo-controlled, dose-ranging studies using ciraparantag demonstrate efficacy and safety in the reversal of apixaban and rivaroxaban

WALTHAM, Mass., July 12, 2020 (GLOBE NEWSWIRE) -- AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced the poster presentation of data from two Phase 2 randomized, placebo-controlled, dose ranging studies which showed safety and efficacy of ciraparantag reversing the effects of apixaban and rivaroxaban in healthy adults age 50-75 years. The poster, “Efficacy and Safety of Ciraparantag in Reversing Apixaban and Rivaroxaban in Healthy Adults” was accepted for the 2020 International Society on Thrombosis and Haemostasis (ISTH) virtual annual meeting. Ciraparantag is in development for use in patients treated with direct oral anticoagulants (DOACs) and low molecular weight heparin (LMWH) when reversal of the anticoagulant effect of these products is needed for emergency surgery, urgent procedures or due to life-threatening or uncontrolled bleeding.

Results from both studies, which randomized a total of 113 subjects, showed that steady-state anticoagulation induced by apixaban or rivaroxaban was reversed by a single IV infusion of ciraparantag in a dose-related manner as assessed by whole blood clotting time (WBCT). WBCT is a direct measure of anticoagulation/hemostasis and a global measure of clotting. Mean WBCT values in the ciraparantag groups decreased toward baseline 15 minutes after dosing, versus placebo which took five hours commensurate with the decline of anticoagulant drug concentration. For reversal, defined as achieving a WBCT ≤10% above baseline within one hour after dosing and subsequently sustained through at least five hours, this response was achieved in 100 percent of subjects receiving ciraparantag doses ≥60 mg for reversal of apixaban, and 100 percent of subjects receiving ciraparantag doses of 180 mg for reversal of rivaroxaban. Ciraparantag was well tolerated at all doses evaluated in these studies. The most frequent adverse events associated with ciraparantag were mild, transient sensations of warmth or flushing, which were observed more frequently with higher doses of ciraparantag.

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