login
  Password reminder
Cardiovascular News
Contact the editor Visit Cardiovascular News Twitter feed Visit Cardiovascular News Facebook page
 

Janssen withdraws supplemental new drug application for rivaroxaban


Tuesday, 10 Jul 2012 14:31

Janssen R&D has announced it is withdrawing the supplemental new drug application (sNDA) to the FDA for the use of rivaroxaban (Xarelto, Bayer/Janssen) to reduce the risk of stent thrombosis in patients with acute coronary syndrome (ACS).


The company is withdrawing this sNDA because it is contingent on a separate sNDA, for rivaroxaban to reduce 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 2012. Data from the ATLAS ACS 2 TIMI 51 trial support both sNDAs.

“We remain confident in the overall study results from the ATLAS ACS 2 TIMI 51 trial, including the observed reduction in stent thrombosis that formed the basis for this separate sNDA,” said Burton. “Our top priority is to work with FDA on our original sNDA for ACS and submit our reply to the complete response letter as soon as possible. We plan to resubmit the sNDA for stent thrombosis at the same time.”




Add New Comment

Most popular


Joint consensus on antithrombotic use in AF patients with acute coronary syndrome published
Wednesday, 27 Aug 2014
A new European joint consensus document on the use of antithrombotic drugs in patients with atrial fibrillation presenting with an acute coronary syndrome and undergoing percutaneous coronary ... Joint consensus on antithrombotic use in AF patients with acute coronary syndrome published

No severe paravalvular leak with Acurate Neo TF
Monday, 29 Sep 2014
Data presented at PCR London Valves (28–30 September, London, UK) indicate that the Acurate Neo transfemoral TAVI system, which recently received the CE mark, is not associated with any incidences of ... No severe paravalvular leak with Acurate Neo TF

ABSORB II study shows Absorb is comparable to Xience drug-eluting stent
Wednesday, 17 Sep 2014
At one year, overall clinical outcomes for Absorb (Abbott) were comparable to Xience (Abbott), and people treated with Absorb experienced a significantly lower rate of angina. ABSORB II study shows Absorb is comparable to Xience drug-eluting stent

Features


The promise of chemical renal denervation
Friday, 05 Sep 2014
Tim A Fischell writes that chemical renal denervation using ethanol may have numerous advantages over energy-based “burning” technologies. The promise of chemical renal denervation

Drug-coated balloons for the management of coronary artery disease
Thursday, 04 Sep 2014
Robert Byrne writes that although drug-coated balloon therapy has been a significant innovation with relevance for everyday practice, convincing data in the coronary arena exists thus far only for ... Drug-coated balloons for the management of coronary artery disease

Profiles


Sunil Rao
Thursday, 23 Oct 2014
Sunil Rao speaks to Cardiovascular News about his career highlights, including his research into ... Sunil Rao

Azeem Latib
Wednesday, 24 Sep 2014
Azeem Latib (senior interventional cardiologist, San Raffaele Hospital and EMO-GVM Centro Cuore C... Azeem Latib

Cardiac Rhythm News Vascular News Cardiovascular News Interventional News Spinal News NeuroNews
BIBA Medical BIBA MedTech Insights CX Symposium ilegx
 
Password Reminder

BIBA Medical, 526 Fulham Road, Fulham, London, SW6 5NR.
TEL: +44 (0)20 7736 8788 FAX: +44 (0)20 7736 8283 EMAIL: 
info@bibamedical.com
© BIBA Medical Ltd is a company registered in England and Wales with company number 2944429.
VAT registration number 730 6811 50.
Site Map | Terms and Conditions