FDA has Xarelto concerns

Published on 02/07/13 at 08:24am

The FDA is unsure about an application to further extend the licence for Janssen and Bayer HealthCare’s blood thinner Xarelto to cover a rare complication in heart patients, and has asked for more information.

The US regulator has issued a complete response letter for a supplemental New Drug Application (sNDA) for the pill to reduce the risk of stent thrombosis in people with acute coronary syndrome (ACS).

The uncommon condition occurs when blood pools at the site of stents implanted in patients’ coronary arteries - about 1.5 million people have these fitted each year and complications with potentially serious consequences, such as heart attack or death, can result.

“We remain confident in the results of the ATLAS ACS 2 TIMI 51 trial and are in ongoing discussions with the FDA regarding this sNDA,” said Christopher Nessel, Janssen’s cardiovascular franchise medical leader.

The Phase III ATLAS programme has also supported a different sNDA for Xarelto to lower the risk of cardiovascular events in ACS patients - for which Janssen has now received two other complete response letters from the FDA.

Last year an FDA panel of medical experts said it could not recommend the oral Factor Xa inhibitor for this new indication, expressing concern about missing clinical trial data and high bleeding risks.

ACS happens when a coronary artery is blocked by a blood clot, disrupting blood supply in a way which may lead to heart attack - or unstable angina, a condition which often presages an attack.

Xarelto is in competition with two other new oral blood thinners - Pfizer and BMS’ Eliquis and Boehringer’s Pradaxa - and Janssen knows that being approved for ACS treatment would be a major step forward for the brand.

Xarelto is already approved for several uses in the US, including to reduce the risk of blood clots in the legs and lungs of people who have just had knee replacement surgery, and to reduce this risk in people who have just had hip replacement surgery.

It is also licensed to reduce the risk of both hemorrhagic and thrombotic strokes as well as other blood clots in people with atrial fibrillation not caused by a heart valve problem.

Adam Hill

http://www.pharmafile.com/news/179899/fda-has-xarelto-concerns?