FDA’s Cardio-Renal AdComm Losing Some Of Its Anticoagulant Experience
Mori Krantz and Sanjay Kaul are rotating off the committee after participating in all three reviews of J&J/Bayer’s Factor Xa inhibitor rivaroxaban, and nearly all of the meetings on novel anti-clotting agents.
You may also be interested in...
Bristol/Pfizer’s Eliquis secures an attractive FDA label for atrial fibrillation on three key fronts: superior stroke prevention, reduced major bleeding and reduced all-cause mortality. With its superiority in preventing hemorrhagic strokes, Eliquis has the clear lead in terms of safety. But Boehringer’s competing Pradaxa remains the only new oral anticoagulant with proven superiority for preventing purely ischemic strokes, which is the main goal of atrial fibrillation treatment.
Some members of FDA’s Cardiovascular and Renal Drugs Advisory Committee questioned whether the high rate of study dropouts and consent withdrawals in rivaroxaban’s pivotal trial for acute coronary syndromes resulted from elements of the trial’s design, including patient consent and follow-up procedures and the primary analysis.
Despite the agency’s decision to limit discussion about missing data to the ATLAS pivotal trial of rivaroxaban, Cardio-Renal advisory committee members suggested reforms that sponsors should consider to prevent the kinds of problems seen in ATLAS.