Rivaroxaban News and Research

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Janssen receives FDA complete response letter for XARELTO sNDA

Janssen Research & Development, LLC (Janssen R&D) announced today the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding a supplemental New Drug Application (sNDA) for XARELTO (rivaroxaban) for the reduction of the risk of secondary cardiovascular events in patients with acute coronary syndrome (ACS).

22 Jun 2012

BioInvent, ThromboGenics announce results from TB-402 Phase IIb trial on VTE

ThromboGenics NV and co-development partner BioInvent International announce today the results from a Phase IIb trial comparing TB-402, a long acting anticoagulant, against rivaroxaban, an oral anticoagulant.

5 Jun 2012

Janssen’s NUCYNTA ER tablets more effective in providing pain management in adults with DPN

Janssen Pharmaceuticals, Inc. today announced the results of an investigational Phase 3 study suggesting NUCYNTA ER (tapentadol) extended-release tablets were significantly more effective than placebo in providing pain management among adults with chronic moderate to severe, painful diabetic peripheral neuropathy.

18 May 2012

Janssen submits XARELTO sNDA with FDA to reduce risk of stent thrombosis in ACS patients

Janssen Research & Development, LLC announced today that it has submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the use of XARELTO, an oral anticoagulant, to reduce the risk of stent thrombosis in patients with Acute Coronary Syndrome.

10 May 2012

Rivaroxaban found safe and effective in pulmonary embolism

Rivaroxaban has been found to be effective in the prevention of venous thromboembolism (VTE) after orthopedic surgery, for the prevention of stroke in AF (Atrial fibrillation) patients, and as additional therapy to conventional antiplatelet therapy in ACS (Acute coronary syndrome) patients.

27 Mar 2012

Rivaroxaban safer, effective than standard therapy in treating PE

A novel oral anti-coagulant outperformed the injected standard therapy on important safety measures for initial and long-term treatment of pulmonary embolism - a blockage of lung blood vessels usually caused by a clot - and showed comparable efficacy, according to data from the EINSTEIN-PE trial presented today at the American College of Cardiology's 61st Annual Scientific Session.

27 Mar 2012

FDA takes more time to decide on the fate of BMS & Pfizer’s joint venture anticlotting drug Eliquis

The U.S FDA have pushed back the deadline for deciding whether to approve an experimental anticlotting drug developed jointly by Pfizer Inc. and Bristol-Myers Squibb Co. The companies said late Wednesday that the Food and Drug Administration has set a new target date of June 28 for deciding whether to approve Eliquis. That’s three months later than originally scheduled.

2 Mar 2012

FDA assigns Priority Review designation to JRD's XARELTO sNDA

Janssen Research & Development, LLC (JRD) announced today that the U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) filed on December 29, 2011 for XARELTO (rivaroxaban), an oral anticoagulant, to reduce the risk of thrombotic cardiovascular events in patients with Acute Coronary Syndrome (ACS).

27 Feb 2012

New blood-thinning drugs likely to replace Coumadin for patients with non-valvular AF

Within a few years, a new generation of easy-to-use blood-thinning drugs will likely replace Coumadin for patients with irregular heartbeats who are at risk for stroke, according to a journal article by Loyola University Medical Center physicians.

7 Feb 2012

New drug might effectively prevent clot-related strokes in patients with AF

For patients with a type of irregular heart beat called atrial fibrillation (AF), a new anti-clotting drug might be better at preventing clot-related strokes while minimizing the risk of causing a bleeding stroke.

3 Feb 2012

Occasional erratic heart rhythms cause about one-fifth of unexplained strokes

Occasional erratic heart rhythms appear to cause about one-fifth of strokes for which a cause is not readily established, according to research presented at the American Stroke Association's International Stroke Conference 2012.

3 Feb 2012

Johnson & Johnson fourth quarter sales increase 3.9% to $16.3 billion

Johnson & Johnson today announced sales of $16.3 billion for the fourth quarter of 2011, an increase of 3.9% as compared to the fourth quarter of 2010. Operational sales increased 4.0% and the negative impact of currency was 0.1%.

24 Jan 2012

Enrollment complete in ThromboGenics, BioInvent TB-402 Phase IIb trial on VTE

ThromboGenics NV and co-development partner BioInvent International announce today that they have completed the enrolment of a 632-patient Phase IIb trial with their novel long-acting anticoagulant TB-402 for the prophylaxis of venous thromboembolism (VTE) after total hip surgery. The trial has recruited patients from 36 centers across Europe.

17 Dec 2011

Xarelto (rivaroxaban) shows success as blood thinner in acute coronary syndrome

A new anti-blood clotting drug – Xarelto (rivaroxaban) has shown clinical success. It may help people with “acute coronary syndrome” lower their risk of death, subsequent heart attack or stroke, a new study finds. Acute coronary syndrome is term that includes people with angina or prior history of heart attack.

15 Nov 2011

Bayer and J&J’s blood thinner drug triumphs at late phase clinical trial

Drug makers Bayer AG and Johnson & Johnson’s new blood clot preventing drug can provide life-saving benefits at very low doses in patients who suffer from acute coronary syndrome finds a new clinical trial.

14 Nov 2011

BIDMC researcher says improvement in survival rates best 'since introduction of aspirin'

An oral anti-clotting drug, when added to standard medical treatment for acute coronary syndrome, lowered the risk of death, heart attack or stroke an average of 16 percent, according to research presented at the American Heart Association's Scientific Sessions.

14 Nov 2011

Janssen receives FDA approval for Xarelto to prevent stroke in people with AF

The U.S. Food and Drug Administration today approved the anti-clotting drug Xarelto (rivaroxaban) to reduce the risk of stroke in people who have abnormal heart rhythm.

5 Nov 2011

FDA panel votes 9-2 in favor of new blood thinner drug

A new stroke preventer from Bayer and Johnson & Johnson – Xarelto moved one step closer to U.S. approval, but questions remained about restrictions on labeling and the need for more studies.

9 Sep 2011

Cardiovascular and Renal Drugs Advisory Committee recommends FDA approval of J&JPRD's rivaroxaban

Johnson & Johnson Pharmaceutical Research and Development, L.L.C. (J&JPRD) announced today that the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee recommended approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation.

9 Sep 2011

FDA stalls the blood-thinner Xarelto’s approval citing inadequate evidence

The Food and Drug Administration (FDA) said in a staff report released today that “there is insufficient information about the drug to determine whether it is safe for use with its proposed labeling.” Their report questions its safety and effectiveness, saying a new study is needed.

6 Sep 2011