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

Regorafenib to be tested in brain cancer patients …

Bayer announced that the regorafenib arm of the platform trial "GBM AGILE" (Glioblastoma Adaptive Global Innovative Learning Environment) opened for enrollment in the US ...

Sanofi and Google to develop new healthcare Innova…

Sanofi and Google will establish a new virtual Innovation Lab with the ambition to radically transform how future medicines and health services are delivered by tapping i...

Bristol-Myers Squibb provides update on pending me…

Bristol-Myers Squibb Company (NYSE: BMY) today provided an update on the approval process and timeline for the Company’s pending merger with Celgene Corporation (NASDAQ: ...

Artificial DNA can control release of active ingre…

A drug with three active ingredients that are released in sequence at specific times: Thanks to the work of a team at the Technical University of Munich (TUM), what was o...

LEO Pharma completes the acquisition of Bayer’s pr…

LEO Pharma and Bayer announced today the achievement of the relevant closing conditions to allow the transfer of Bayer’s global prescription dermatology business to LEO P...

Pathogen engineered to self-destruct underlies can…

A team of investigators has developed a cancer vaccine technology using live, attenuated pathogens as vectors. A feature of the vaccine causes these bacteria to self-dest...

Novartis successfully completes acquisition of Xii…

Novartis today announced that it has completed its acquisition of Xiidra® (lifitegrast ophthalmic solution) 5%, the first and only prescription treatment approved to trea...

How gastric stem cells fight bacteria

Stem cells are not only key players in tissue regeneration, they are also capable of taking direct action against bacteria. This is the finding of a study conducted by re...

New study showing drug prolongs life for patients …

Women with ovarian cancer who have undergone four or more rounds of chemotherapy typically haven't had much hope that another treatment option will lengthen their lives i...

Pfizer completes acquisition of Therachon

Pfizer Inc. (NYSE: PFE) announced the successful completion of its acquisition of the privately held clinical-stage biotechnology company Therachon Holding AG. Under the ...

Sports playbook helps doctors predict cancer patie…

In this season of global soccer competitions and hotly contested political primaries, bookies and pundits are scouring every evolving scrap of information and sifting thr...

FDA seeks public feedback on new drug approval tra…

Today the U.S. Food and Drug Administration issued a Federal Register notice, New Drugs Regulatory Program Modernization: Improving Approval Package Documentation, to ope...