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


Abbott to acquire St Jude Medical
Tuesday, 03 May 2016
Abbott is set to acquire St Jude Medical, expanding its portfolio to cover cardiovascular markets such as atrial fibrillation, structural heart and heart failure as well as neuromodulation. The ... Abbott to acquire St Jude Medical

French hospital celebrates 30 years of implanting artificial hearts
Wednesday, 13 Apr 2016
La Pitié-Salpêtrière Hospital (Paris, France), the world’s leading artificial heart centre, is celebrating the 30th anniversary of the first Total Artificial Heart implantation. The centre has now ... French hospital celebrates 30 years of implanting artificial hearts

Tuesday, 05 Apr 2016
One-month, follow-up patient cohort data from the Revelution trial of Medtronic’s novel drug-filled stent indicate that device is associated with rapid vessel healing without inflammation, as ... Early data show good rapid healing for Medtronic’s investigational drug-filled stent

Features


Exploring the role of P2Y12 inhibitor monotherapy after dual antiplatelet therapy
Monday, 09 May 2016
According to Usman Baber, TWILIGHT is a unique and innovative study in that the experimental intervention is to withdraw rather than add to existing background pharmacotherapy. In this commentary, he ... Exploring the role of P2Y12 inhibitor monotherapy after dual antiplatelet therapy

The role of sutureless and rapid-deployment valves
Tuesday, 05 Apr 2016
Antonio Miceli explores the data for sutureless and rapid-deployment surgical valves for the management of patients with severe aortic stenosis. He also reviews the place of these new devices ... The role of sutureless and rapid-deployment valves

Profiles


Alexandra Lansky
Monday, 07 Mar 2016
Alexandra Lansky (Director, Heart and Vascular Clinical Research Program, Yale University School of ... Alexandra Lansky

Corrado Tamburino
Tuesday, 20 Oct 2015
Corrado Tamburino (full professor of Cardiology, Ferrarotto & Policlinico Hospitals, University of C... Corrado Tamburino

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