(Reuters) - A panel of European Medicines Agency on Friday recommended against granting marketing approval to Portola Pharmaceuticals Inc’s oral blood thinner, saying the benefits of the drug did not outweigh risks.
The Committee for Medicinal Products for Human Use (CHMP) said patients treated with Dexxience had more episodes of bleeding than those treated with the comparator medicine.
Dexxience, also known as betrixaban, is a treatment to prevent deep vein thrombosis and pulmonary embolisms in acutely ill patients who are not undergoing surgery.
The decision comes a month after CHMP informed the company of a negative trend vote for betrixaban. (bit.ly/2FXvYuE)
While final approvals are up to the European Commission, it generally follows CHMP’s recommendation and endorses them within a couple of months.
The drug, which was approved by the U.S. Food and Drug Administration in June, competes with injectable medications heparin and Sanofi TA’s Lovenox, which are typically used in hospitals for short durations.
Deep vein thrombosis (DVT) is a medical condition that occurs when a blood clot forms in a deep vein, usually in the lower leg, thigh or pelvis.
The most serious complication of DVT happens when a part of the clot breaks off and travels through the bloodstream to the lungs, causing a blockage called pulmonary embolism.
Reporting by Radhika Rukmangadhan in Bengaluru; Editing by Arun Koyyur and Anil D'Silva