New AF possibility for Xarelto
pharmafile | March 11, 2013 | News story | Sales and Marketing | Bayer, FDA, Xarelto
Bayer HealthCare is to launch a new trial of its oral blood thinner Xarelto just days after the FDA knocked back a new application for the drug in patients with acute coronary syndrome.
The new Phase IIIb study will look at Xarelto (rivaroxaban) in patients with non-valvular atrial fibrillation (AF) who have percutaneous coronary intervention (PCI) with stent placement.
The PIONEER AF-PCI study is to enrol 2,100 patients worldwide, using two Xarelto treatment strategies and a dose-adjusted vitamin K antagonist (VKA) one over 12 months.
Bayer markets the drug outside the US, with Janssen Pharmaceuticals having the rights in the US – where the FDA has just asked for more information in a move which puts another potential new indication in doubt.
Janssen is attempting to get Xarelto (rivaroxaban) authorised for the reduction of cardiovascular events in patients with acute coronary syndrome (ACS). The Factor Xa inhibitor already has half a dozen indications in the US but the supplemental new drug application (sNDA) in ACS has proved a sticking point.
The most recent complete response letter is the second sent by the FDA on this sNDA. “Janssen is evaluating the letter and will respond to the agency’s questions,” the manufacturer said in a statement.
In February last year the FDA gave Xarelto a priority review designation in ACS: it issued its first complete response letter in June, to which Janssen responded in September.
The data Janssen included that time related to patients who had withdrawn from the Phase III ATLAS ACS 2 TIMI 51 trial for Xarelto in ACS. This trial, along with the Phase II ATLAS ACS 2 TIMI 46, has great weight in the new sNDA and Janssen is standing by its results.
“We remain confident in the robustness and results of the ATLAS ACS 2 TIMI 51 trial, evidenced by a significant reduction in cardiovascular events, including a clinically important decrease in cardiovascular death,” said Janssen vice president Christopher Nessel.
“While we saw an increase in major bleeding, there was no increase in fatal bleeding,” he added. “We will continue to work with the FDA to address their questions.”
ACS is a complication of coronary heart disease which occurs when a blood clot blocks a coronary artery, reducing blood supply to the heart. This disruption of blood flow can cause a heart attack, or unstable angina, a condition signifying that a heart attack may soon occur.
Xarelto is already indicated to reduce the risk of blood clots in the legs and lungs of people who have just had knee or hip replacement surgery.
It can also be used to in patients with AF at risk of hemorrhagic and thrombotic strokes, and to treat pulmonary embolism and deep vein thrombosis and to reduce the risk of their recurrence.
Its main rivals at present are Pfizer and BMS’ Eliquis and Boehringer’s Pradaxa, which gained US approval in 2010 for use in AF.
Adam Hill
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