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Priority review for Xarelto’s new indications

Published on 10/07/12 at 10:20am
Xarelto image

Xarelto is to be given a FDA fast-track review for a range of anti-blood clotting uses.

Xarelto (rivaroxaban) gained its first US approval a year ago for the prevention of deep vein thrombosis (DVT) in orthapaedic surgery, and then gained approval for the prevention of stroke in patients with atrial fibrillation in November.

The drug is marketed in the US by Janssen, and is part of a competitive field of new oral treatments. Its main competitor is Boehringer Ingelheim’s Pradaxa, with Pfizer’s Eliquis also awaiting its first approval.

Janssen is now seeking new additional indications to treat patients with DVT, pulmonary embolism (PE), and to prevent recurrent DVT and PE.

DVT is a condition in which blood clots form in one of the large, deep veins, usually in the legs. PE is a serious condition that most commonly occurs when part or all of a DVT dislodges and is carried to the lung, via the heart, where it can partially or completely block a branch of the pulmonary artery.

“We are delighted to have received a priority review designation for Xarelto for the treatment of PE and DVT, and also to prevent the recurrence of these conditions. Each year an estimated 900,000 Americans experience a DVT or PE, and one third of those events are fatal.

“If approved for these indications, Xarelto has the potential to address critical unmet needs in treating patients with these serious medical conditions,” said Paul Burton, VP, Cardiovascular Franchise Medical Leader at Janssen R&D.

The FDA grants priority review to medicines that offer major advances in care or provide a treatment where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), FDA will aim to complete its review within six months, rather than the standard 10-month period.

The submissions are supported by data from the global EINSTEIN programme, which includes two Phase III studies evaluating the safety and efficacy of rivaroxaban in the treatment of patients with acute symptomatic DVT or PE, and the prevention of recurrent events in these patients.

A third phase III study evaluated the safety and efficacy of rivaroxaban in the long-term prevention of recurrent DVT and PE. In total, these Phase III studies included more than 9,400 patients.

Problems with stent thrombosis filing

There was less encouraging news for Janssen, as it also announced the withdrawal of a filing for the use of Xarelto to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome (ACS). 

The company is withdrawing this filing because it is dependent on another application, for Xarelto to reduce of the risk of secondary cardiovascular events in patients with ACS, which Janssen R&D received a complete response letter from the FDA on 21 June this year. Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.

FDA experts said they could not recommend the ACS filing, because a large number of patients dropped out of the trial, creating gaps in the data which many felt was too great.

Janssen says it is confident about the ATLAS ACS 2 TIMI 51 trial, including the observed reduction in stent thrombosis that formed the basis for the separate sNDA.

The firm says it will work with US regulator on the ACS filing and reply to the complete response letter as soon as possible, and also plans to resubmit the filing for stent thrombosis at the same time.

Stent thrombosis is an uncommon, but potentially catastrophic complication that may occur after a stent has been inserted into a patient's coronary artery and can result in a heart attack or even death. Coronary stents are implanted in more than 1.5 million patients each year.

There are four filings currently submitted to the FDA. Three are under review and the fourth, for the ACS indication, is pending reply to the complete response letter. Rivaroxaban is co-marketed by Janssen and Bayer.

Andrew McConaghie

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