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FDA panel votes 9-2 in favor of new blood thinner drug

June 18, 2017

Earlier this week, FDA reviewers said for conditions such as stroke, which can cause irreversible harm, new drugs must be shown to be at least as effective as older treatments, and called for the agency to delay Xarelto's approval.

In Thursday's meeting, panel members also focused on risks for patients when they come off the drug. Patients who stopped taking Xarelto and resumed warfarin at the end of the main clinical trial had a higher risk of stroke, a so-called ???rebound??? effect.

???Additional data probably should be obtained regarding how to transition (off of Xarelto) prior to approval,??? said Dr. Michael Lincoff, chair of the panel and professor of medicine at the Cleveland Clinic.

The FDA is set to make the final decision on Xarelto by Nov. 4, Johnson & Johnson said.

Dr Peter Dibattiste, global head of J&J's cardiovascular and metabolic division, said the company will discuss with the FDA the need for additional studies. A study looking at how long Xarelto lasted in patients could be relatively quick, ???probably months,??? he said.

A delay for Xarelto could give the edge to a rival treatment called Eliquis being developed by Bristol-Myers Squibb and Pfizer Inc. Eliquis, also called apixaban, showed superiority over warfarin in effectiveness, safety and saving lives in a clinical trial presented last month at a scientific meeting in Paris, affirming its place as the potential leader of the pack. Xarelto is approved in the United States and Europe for anti-clotting in patients after knee and hip surgery, a much smaller market than stroke prevention for AF patients.