The first new drug approved by FDA in 2015: oral anticoagulant savaysa

2014 was a bumper year, with 41 new molecular entities (NME) and biologicals licensing applications (BLA) approved by FDA On January 8, the U.S FDA welcomed the first new drug, and approved the new anticoagulant XA factor inhibitor, savaysa (general name: edoxaban) from Daiichi Sankyo, for stroke and systemic embolism in patients with non valvular atrial fibrillation (NVAF) This is the fourth FDA approved oral anticoagulant Savaysa was also approved for treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) in patients who had received anticoagulants for five to ten days As early as 2011savaysa was listed in Japan under the trade name lixiana On January 9, 2014, DS submitted NDA to FDA On October 30, 2014, the drug was approved by FDA It was recommended to prevent stroke and systemic embolism in patients with nonvalvular atrial fibrillation The company also filed an application with the European Union Savaysa was approved based on two positive phase 3 clinical data: 1 Engage af-timi, a phase 3 clinical trial, recruited 21105 patients with nonvalvular atrial fibrillation, and compared the effects of savaysa and fawarin on stroke prevention and risk reduction of systemic embolism The results showed that high-dose savaysa was equivalent to farwarin in the prevention of stroke, but for the risk of bleeding in patients with AF, savaysa was lower than farwarin 2、 The clinical trial Hokusai VTE recruited 8292 and / or PE patients, and compared the effect of savaysa and fawarin on reducing the recurrence rate of symptomatic VTE (including DVT formation, PE and VTE related deaths) The results showed that savaysa was superior to favalin Of the two clinical manifestations, savaysa was the most common Severe bleeding can be life-threatening Currently, there is no specific drug to reverse the anticoagulant effect of savaysa The launch of savaysa was accompanied by a black box warning to remind medical staff of the dosage and applicable patient groups In patients with AF whose creatinine clearance rate was more than 95 ml / min, the effect of savaysa was not as good as that of farwarin Therefore, FDA suggests that NVAF patients with creatinine clearance rate > 95ml / min should be treated with other anticoagulants When using savaysa, the patient should be informed about the possible risks of using savaysa in person, and the medication guide should be provided At present, the other three anticoagulants on the market are: bairituo (trade name: xarelto, general name: rivaroxban); pradaxa (general name: dabigatran, dabigatran) and eliquis (general name: apixaban, apixaban) These three drugs have been on the market for many years in the United States, and they are superior to the old drug forest in both safety and ease of use As a result, savaysa also faces many problems after its marketing, but the marketing of the drug still gives medical staff and patients more choices.