An antidote intended for uncontrolled bleeding linked to blood thinners was not approved by the U.S. Food and Drug Administration (FDA), according to Portola Pharmaceuticals, the maker.
Blood thinners are prescribed by doctors to prevent blood clots and strokes after surgery and also for people with atrial fibrillation. Warafin (Coumadin) was the go-to drug for decades. But newer anticoagulants including Xarelto don’t require blood tests or dietary restrictions like that of Warfarin.
“Because AndexXa addresses an urgent unmet medical need, we and the FDA are committed to resolving the outstanding questions and determining appropriate next steps. Portola’s goal is to define the most expedient path to approval so we can meet the needs of these patients who have no alternative,” Bill Lis, chief executive officer of Portola, said in a statement. “We plan to meet with the FDA as soon as possible.”
Portola received the FDA’s letter on August 17 in response to its application for the approval of AndexXa. At that time the agency requested more information regarding manufacturing and stated it needs to review the changes Portola made to its post-marketing commitments.
The company is expecting to resubmit an application to the FDA before year-end.