FDA report reaffirms safety profile and effectiveness of Bayer's Xarelto® in routine clinical practice

BayerA report from the U.S. Food and Drug Administration (FDA) published in Pharmacoepidemiology & Drug Safety confirms the safety profile and effectiveness of Xarelto® (rivaroxaban) in people with atrial fibrillation (AF). The study is based on electronic healthcare data within the Mini-Sentinel safety programme in the US, reporting data on a large real-world population of over 115,000 people prescribed rivaroxaban or warfarin.

To examine the safety of both products, rates of gastrointestinal bleeding, ischemic stroke and intracranial haemorrhage in people with AF were evaluated. Findings from the study - part of the active drug safety surveillance of the FDA - noted that a lower risk of ischemic stroke and intercranial haemorrhage was associated with the use of rivaroxaban compared to warfarin, whilst the risk of gastrointestinal bleeding was lower with warfarin.

"We welcome the results of this safety analysis of Xarelto from the FDA, which are consistent with the findings we have seen in both our clinical trials and real-world studies," said Dr. Michael Devoy, Head of Medical Affairs & Pharmacovigilance of Bayer AG's Pharmaceuticals Division and Bayer Chief Medical Officer. "These FDA findings again confirm the positive benefit-risk profile of Xarelto in people with non-valvular AF."

The Sentinel Initiative began in 2008 as a multi-year program to create a national electronic system for monitoring the safety of approved and FDA-regulated medical products using electronic healthcare data from multiple sources in the US. The Mini-Sentinel is a working pilot project to develop an active surveillance system and to complement existing methods of safety monitoring.

For the full report, please visit: http://onlinelibrary.wiley.com/doi/10.1002/pds.4375/full

About Xarelto® (Rivaroxaban)

Rivaroxaban is the most broadly indicated non-vitamin K antagonist oral anticoagulant (NOAC) worldwide and is marketed under the brand name Xarelto®. Xarelto is approved for seven indications, protecting patients across more venous and arterial thromboembolic (VAT) conditions than any other NOAC:
  • The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) and one or more risk factors
  • The treatment of pulmonary embolism (PE) in adults
  • The treatment of deep vein thrombosis (DVT) in adults
  • The prevention of recurrent PE and DVT in adults
  • The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip replacement surgery
  • The prevention of VTE in adult patients undergoing elective knee replacement surgery
  • The prevention of atherothrombotic events (cardiovascular death, myocardial infarction or stroke) after an Acute Coronary Syndrome in adult patients with elevated cardiac biomarkers and no prior stroke or transient ischaemic attack (TIA) when co-administered with acetylsalicylic acid (ASA) alone or with ASA plus clopidogrel or ticlopidine

Whilst licences may differ from country to country, across all indications Xarelto is approved in more than 130 countries.

Rivaroxaban was discovered by Bayer, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer and in the U.S. by Janssen Pharmaceuticals, Inc. (Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc. are part of the Janssen Pharmaceutical Companies of Johnson & Johnson).

Anticoagulant medicines are potent therapies used to prevent or treat serious illnesses and potentially life-threatening conditions. Before initiating therapy with anticoagulant medicines, physicians should carefully assess the benefit and risk for the individual patient.

Responsible use of Xarelto is a very high priority for Bayer, and the company has developed a Prescriber's Guide for physicians and a Xarelto Patient Card for patients to support best practice.

To learn more about thrombosis, please visit www.thrombosisadviser.com
To learn more about Xarelto, please visit www.xarelto.com

About Bayer

Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. Its products and services are designed to benefit people and improve their quality of life. At the same time, the Group aims to create value through innovation, growth and high earning power. Bayer is committed to the principles of sustainable development and to its social and ethical responsibilities as a corporate citizen. In fiscal 2016, the Group employed around 99,600 people and had sales of EUR 34.9 billion. Capital expenditures amounted to EUR 2.2 billion, R&D expenses to EUR 4.4 billion.

Most Popular Now

Merck Granted U.S. Patent for novel combination of…

Merck, a leading science and technology company, today announced that it has been granted Patent No. US 10,193,695 by the United States Patent and Trademark Office (USPTO...

Forxiga receives positive EU CHMP opinion for the …

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended a new indication for the marketing authorisation of Forxi...

Pfizer receives positive CHMP opinion for Vizimpro…

Pfizer today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending V...

Amgen and UCB receive positive vote from FDA Advis…

Amgen (NASDAQ:AMGN) and UCB (Euronext Brussels: UCB) announced strong support from the U.S. Food and Drug Administration (FDA) Bone, Reproductive and Urologic Drugs Advis...

Pfizer and Lilly announce top-line results from se…

Pfizer Inc. (NYSE:PFE) and Eli Lilly and Company (NYSE:LLY) today announced positive top-line results from a Phase 3 study evaluating tanezumab 2.5 mg or 5 mg in patients...

US FDA grants Breakthrough Therapy Designation for…

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Ther...

Merck welcomes ten new startups to its Innovation …

Merck, a leading science and technology company, today announced the ten startups that will be joining the seventh intake of its Accelerator program at the Merck Innovati...

Merck and Tencent announce collaboration on intell…

Merck, a leading science and technology company, signed a strategic collaboration agreement with Tencent, a leading provider of Internet value added services. The collabo...

Merck to expand US biopharmaceutical R&D facil…

Merck, a leading science and technology company, today announced a $70 million investment to expand its state of the art research and development (R&D) facility in Biller...

New pill can deliver insulin

An MIT-led research team has developed a drug capsule that could be used to deliver oral doses of insulin, potentially replacing the injections that people with type 2 di...

Researchers call for big data infrastructure to su…

Researchers from the George Washington University (GW), the U.S. Food and Drug Administration (FDA), and industry leaders published in PLOS Biology, describing a standard...

New computational method reduces risk of drug form…

One major factor that determines the efficacy of a drug is the structure that its molecules form in a solid state. Changed molecular structures can entail that pills stop...