EMA panel says FDA-approved drug is too risky

March 26, 2018

The EMA’s Committee for Medicinal Products for Human Use (CHMP) says that Portola Pharmaceuticals’ Dexxience, approved by the FDA in June 2017, had more episodes of bleeding than those treated with the comparator medicine.

Dexxience, approved in the U.S. under the name Bevyxxa, is a treatment to prevent deep vein thrombosis and pulmonary embolisms in acutely ill patients who are not undergoing surgery.

During the U.S. approval process, the drug, given Fast Track designation by the FDA, struggled in a phase 3 trial, forcing Portola to reanalyze the data to make its case for approval. The re-casted data from the trial showed that venous thromboembolism events were reduced up to 45 percent in patients taking Bevyxxa.

While final approvals in the EU are up to the European Commission, it generally follows CHMP’s recommendation. Portola intends to appeal the opinion and seek a re-examination by the CHMP.