Pharmaceutical sponsors across therapeutic categories may have breathed a sigh of relief when FDA’s Cardiovascular and Renal Drugs Advisory Committee said that Bayer/Johnson & Johnson’s Xarelto (rivaroxaban) need not show it is “as effective” as Boehringer Ingelheim GmbH’s anticoagulant Pradaxa (dabigatran) in atrial fibrillation patients.
At the September 8th meeting focused on efficacy data from the pivotal ROCKET AF study and whether the Factor Xa inhibitor was studied against an appropriate comparator. FDA sought the advisory committee’s input on whether warfarin or dabigatran was the appropriate comparator for rivaroxaban in light of a 1995 agency policy that requires new therapies be “as effective” as approved treatments when the disease at issue is life-threatening or capable of causing irreversible morbidity.
At a Sept. 8 meeting, the majority of panel members said Xarelto’s sponsors should not be required to directly show comparable efficacy to dabigatran, a drug approved 11 months ago.
According to the Pink Sheet, panelists commented that requiring drugs for serious or life-threatening diseases to be compared head-to-head against the newest treatment on the block could “throw a wrench in long-planned and ongoing clinical development programs that use a well-established standard of care as a comparator agent.”
Office of Drug Evaluation I Director Bob Temple on the question as to whether or not the ROCKET AF study population represented a sufficiently different group of patients from those in RE-LY as to render the “as effective” policy inapplicable to rivaroxaban:
“This was not my favorite question.” Dr, Temple then proceeded to point out the bigger issue inherent in applying FDA’s “as effective” policy in a dynamic development and regulatory environment.
“There is an interesting and provocative issue here. Suppose in the course of the study, something new and really hot comes along. Do we ever say, ‘I’m sorry, you compared it to a dog, we have something better now?’ We don’t usually do that, but I wouldn’t rule out the possibility. And this is a little bit about that possibility, but I don’t think we really meant to get too much into that discussion.”
