Breaking News
June 23, 2018 - Coconut oil diet increases vitality, lifespan of fruit flies with peroxisomal disorder
June 23, 2018 - Jumping genes or transposons and their role in the genetic code
June 23, 2018 - The Current issue of “The view from here” is concerned with Therapeutics
June 23, 2018 - Abnormal lipid metabolism in fat cells predicts future weight gain and diabetes in women
June 23, 2018 - Alcohol problems linked to sex without condom use among black gay men
June 23, 2018 - DNA patterns in circulating blood cells can help identify spastic cerebral palsy
June 23, 2018 - Unsubstantiated health claims widespread within weight loss industry
June 23, 2018 - FDA grants marketing authorization for use of two catheter-based devices in hemodialysis patients
June 23, 2018 - An ingrown toenail not the same as a bypass
June 23, 2018 - Study suggests proteinuria lowering as important target in managing pediatric CKD
June 23, 2018 - FDA Alert: Kratom (mitragyna speciosa) powder products by Gaia Ethnobotanical: Recall
June 23, 2018 - CDC chief asks for, and gets, cut to his record $375K pay
June 22, 2018 - Novel cellular pathway may clarify how arterial inflammation develops into atherosclerosis
June 22, 2018 - Pioneering exercise program improves physical, mental health of elderly people living in care homes
June 22, 2018 - Rutgers Cancer Institute educates childhood cancer survivors about late effects of treatment
June 22, 2018 - Study tests accuracy of device designed to detect heart dysfunction in childhood cancer survivors
June 22, 2018 - Study links annual haze with increased hospitalizations for respiratory problems
June 22, 2018 - Robotic surgery appears to be as effective as open surgery in treating bladder cancer
June 22, 2018 - Many Drugs Made Available Via FDA Expanded Access Programs
June 22, 2018 - Normal eye dominance is not necessary for restoring visual acuity in amblyopia
June 22, 2018 - Parent-Child Interaction Therapy can reduce depression rates in children
June 22, 2018 - Study provides insights into how components of different cells in the brain are altered
June 22, 2018 - Research does not confirm antidiabetic action of natural fatty acid derivatives
June 22, 2018 - Oxidative stress can be used against tumors to treat cancer
June 22, 2018 - Simple, cost-effective test may help improve early diagnosis of mild cognitive impairment
June 22, 2018 - New guide published to help battle fatal disease caused by kissing bugs
June 22, 2018 - Stigma Adds to Burden of Type 1 Diabetes
June 22, 2018 - In retinoblastoma survivors, oculo-visual issues tied to QoL
June 22, 2018 - Most adults with allergies do not use prescribed epinephrine even in emergency situations
June 22, 2018 - Study provides clues to how cancer cells develop resistance to chemotherapies
June 22, 2018 - New consensus paper serves as basis for uniform medical management of DSD
June 22, 2018 - Researchers work to identify areas of the brain that help us wake up
June 22, 2018 - Alcohol hangovers more significant and costly than people realize, shows research
June 22, 2018 - Targeting cells involved in blood vessel formation could hinder brain tumor growth
June 22, 2018 - Young cancer survivors need more support as they feel dissatisfied with their sexuality
June 22, 2018 - Unusual cell-to-cell communication in glioblastoma promotes aggressiveness and therapy resistance
June 22, 2018 - Turning A Phage – Drug Discovery Today
June 22, 2018 - World-first study links birth interventions and long-term childhood illness
June 22, 2018 - Improving the quality of biomedical research samples
June 22, 2018 - Researchers identify cerebral palsy using AI and DNA sequencing
June 22, 2018 - Administering nitric oxide gas after heart surgery may decrease risk of kidney problems
June 22, 2018 - Measuring levels of ethyl sulphate in hair can help assess alcohol consumption
June 22, 2018 - Researchers develop robot bloodhound that can rapidly detect odors on the ground
June 22, 2018 - AAA doses first patients in two clinical studies with PSMA-R2 for prostate cancer
June 22, 2018 - LSTM led consortium receives grant to investigate how human behavior impacts AMR
June 22, 2018 - Researchers discover drug compound that inhibits movement of cancer cells
June 22, 2018 - Normalization of ‘plus-size’ body shapes may prevent recognition of health risks of obesity
June 22, 2018 - UC San Diego launches new bacteriophage therapy center
June 22, 2018 - New review outlines current state of sex-sensitive issues linked to heart failure drugs
June 22, 2018 - Pelvic pain a major issue for women nearing mid-life, research reveals
June 22, 2018 - Researchers develop reliable DNA barcodes for biomedical research
June 22, 2018 - New risk-prediction model may help identify diabetic patients at high risk of pancreatic cancer
June 22, 2018 - Study reveals how mTORC1-driven changes in crowding could influence major diseases
June 22, 2018 - Researchers uncover new therapeutic opportunity in the treatment of malignant melanoma
June 22, 2018 - UC Riverside researcher receives grants to advance cancer, ALS research
June 22, 2018 - Radiation therapy alone may be enough to treat older, sicker patients with anal cancers
June 22, 2018 - Technical report describes how to make accurate particle size measurements on carbon black samples
June 22, 2018 - Nocdurna (desmopressin acetate) Approved by FDA as First Sublingual Tablet to Treat Nocturia due to Nocturnal Polyuria
June 22, 2018 - Neuroscientists locate neurons in the brain that respond when a visual target is found
June 22, 2018 - First human Keystone virus infection reported
June 22, 2018 - New study reveals how ‘good’ bacteria help in regulating our metabolism
June 22, 2018 - Osteopathic manual therapy affecting the diaphragm improves chronic low back pain
June 22, 2018 - Researchers create revolutionary model to study pulmonary diseases
June 22, 2018 - Diagnosing Heart Disease Using AI
June 22, 2018 - Increasing biodefense risks posed by synthetic biology
June 22, 2018 - Many Women Report Vasomotor Symptoms in Their 60s
June 22, 2018 - Rare mutation of gene carried by Quebec family gives insight into how the brain is wired
June 22, 2018 - Chemists find new way to make enzymes do a non-natural reaction
June 22, 2018 - Summer is good time to check for signs of skin cancer
June 22, 2018 - Innovative method can help identify patients with spastic cerebral palsy
June 22, 2018 - Exercise alters characteristics of blood to reduce inflammation in obese people
June 22, 2018 - Researchers examine complications across different types of breast reconstructive surgeries
June 22, 2018 - Rhesus macaque model could be useful to test therapies for congenital Zika virus syndrome
June 22, 2018 - AHA: New Insights Into Sickle Cell and Stroke Risk
June 22, 2018 - Doctors prescribe opioids at high rates to those at increased overdose risk
June 22, 2018 - Reduction in US cigarette smoking rates
June 22, 2018 - Preconception binge drinking may have negative effect on future offspring
June 22, 2018 - FDA expands approval of novel diabetes management device to include younger pediatric patients
June 22, 2018 - Researchers confirm weight loss benefits of the 16:8 diet
June 22, 2018 - FDA approves Eversense CGM system for use in adults with diabetes
FDA Approves New 10 mg Dosing for Xarelto (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE)

FDA Approves New 10 mg Dosing for Xarelto (rivaroxaban) to Reduce the Continued Risk of Venous Thromboembolism (VTE)

image_pdfDownload PDFimage_print

TITUSVILLE, NJ, OCTOBER 30, 2017 – Janssen Pharmaceuticals, Inc. announced today the U.S. Food and Drug Administration (FDA) approved the 10 mg once-daily dose of Xarelto (rivaroxaban) for reducing the continued risk for recurrent venous thromboembolism (VTE) after completing at least six months of initial anticoagulation therapy. This approval follows a FDA Priority Review and is based on data from EINSTEIN CHOICE, the only clinical study to find that a Factor Xa inhibitor, specifically Xarelto, demonstrates superior efficacy in reducing the continued risk of recurrent VTE and with major bleeding rates similar to aspirin.

VTE includes deep vein thrombosis (DVT), a blood clot in a deep vein (often the legs), and pulmonary embolism (PE), a clot that travels to the lung. It is the third most common cause of cardiovascular death worldwide, after heart attack and stroke.

“We believe the availability of the 10 mg Xarelto dose will change clinical practice and the management of VTE recurrence,” said Paul Burton, MD, PhD, FACC, Vice President, Medical Affairs, Janssen. “The landmark EINSTEIN program results yet again demonstrate Xarelto is a safe and highly effective option, not only for the initial treatment of a VTE, but also for the continued prevention of a recurrent event.”

With this approval, the Xarelto prescribing information provides instructions for physicians to begin treatment with Xarelto 15 mg, dosed twice daily, for the first 21 days after a VTE occurrence. On day 22 through at least day 180, the daily dose decreases to Xarelto 20 mg once daily. After at least 180 days (6 months), physicians can prescribe Xarelto 10 mg once daily in patients at continued risk for DVT and/or PE.

“If anticoagulation therapy is stopped, up to 20 percent of patients will have a recurrent VTE within three years. To prevent this, physicians have long debated how best to extend anticoagulant use beyond the initial treatment window,” said Jeffrey Weitz, MD, FRCP(C), FACP, Professor, Departments of Medicine and Biochemistry and Biomedical Sciences, McMaster University, and Executive Director, Thrombosis & Atherosclerosis Research Institute. “The FDA’s approval of the 10 mg dose of Xarelto for preventing recurrent VTE, along with clinical evidence confirming the superiority of Xarelto over aspirin for extended VTE prevention, means we can finally put this debate to rest.”

The FDA’s approval of the Xarelto 10 mg once-daily dose was based on the EINSTEIN CHOICE study results. The EINSTEIN CHOICE study evaluated patients with VTE who were already treated with six to 12 months of initial anticoagulation therapy and then received Xarelto 10 mg once daily, Xarelto 20 mg once daily or aspirin 100 mg once daily for up to an additional 12 months of treatment. Patients taking either Xarelto dose had significantly fewer recurrent VTE compared to those taking aspirin. Specifically, Xarelto 10 mg reduced the risk of recurrent VTE by 74 percent and Xarelto 20 mg by 66 percent. All three treatment groups had low rates of major bleeding (0.4 percent with Xarelto 10 mg, 0.5 percent with Xarelto 20 mg, 0.3 percent with aspirin).

In September 2017, Janssen’s development partner Bayer announced the Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion to update the Xarelto label to include the 10 mg once-daily dose in the European Union; the European Commission granted approval on October 19, 2017.

About EINSTEIN CHOICE

EINSTEIN CHOICE is a Phase 3, global, randomized, double-blind, superiority study that compared the efficacy and safety of two doses of Xarelto (10 mg and 20 mg once daily) with aspirin 100 mg once daily for the management of VTE. The study met its primary efficacy endpoint, finding both Xarelto doses to be superior to aspirin in reducing the risk of recurrent VTE. There were 3,365 patients from 31 countries included in the study analysis. People who required extended anticoagulation at therapeutic doses were not included, as the study’s objective was to investigate patients for whom the treating physician was uncertain about the need for continuing anticoagulant therapy.

Data from EINSTEIN CHOICE were presented during a joint American College of Cardiology/Journal of the American Medical Association Late-Breaking Clinical Trials session at the American College of Cardiology’s 66th Annual Scientific Session in March 2017 and simultaneously published in The New England Journal of Medicine.

About EXPLORER

The EXPLORER program is unmatched by any oral anticoagulant in the Factor Xa inhibitor class in its size, scope and ambition. A collaborative effort between Janssen and Bayer, EXPLORER seeks to generate important clinical evidence on the safety and efficacy of Xarelto and its potential role in addressing critical unmet medical needs. Several studies in the program, including EINSTEIN CHOICE, are designed to seek additional indications or expand the label for Xarelto to benefit more patients in need of additional therapies for their cardiovascular disease. By the time of its completion, more than 275,000 patients will have participated in the EXPLORER clinical development program, other completed and ongoing clinical trials, investigative registries and non-interventional studies.

About the Janssen Pharmaceutical Companies

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science.

We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com. Follow us on Twitter at @JanssenUS.

Cautions Concerning Forward-Looking Statements

This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding the availability and benefits of the 10 mg dose of XARELTO® (rivaroxaban). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Pharmaceuticals, Inc., any of the other Janssen Pharmaceutical Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended January 1, 2017, including under “Item 1A. Risk Factors,” its most recently filed Quarterly Report on Form 10-Q, including under the caption “Cautionary Note Regarding Forward-Looking Statements,” and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Janssen Pharmaceutical Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.

Source: Janssen Pharmaceuticals, Inc.

Posted: October 2017

Related Articles:

  • FDA Issues Complete Response Letter for Xarelto (rivaroxaban) to Reduce the Risk of Stent Thrombosis in Patients with Acute Coronary Syndrome – June 28, 2013
  • FDA Expands Use of Xarelto to Treat, Reduce Recurrence of Blood Clots – November 2, 2012
  • FDA Approves Xarelto to Prevent Stroke in People With Common Type of Abnormal Heart Rhythm – November 4, 2011
  • FDA Approves Xarelto (rivaroxaban) to Prevent Deep Vein Thrombosis in Patients Undergoing Knee or Hip Replacement Surgery – July 1, 2011
  • New Drug Application Submitted to FDA for Rivaroxaban for Prevention of Stroke in Patients with Atrial Fibrillation – January 5, 2011
  • New Drug Application for Rivaroxaban in the U.S. – July 16, 2009
  • U.S. FDA Issues Complete Response Letter for Rivaroxaban – May 28, 2009
  • FDA Advisory Committee Finds Favorable Risk-Benefit Profile for Oral Anticoagulant Rivaroxaban for Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism After Hip or Knee Replacement Surgery – March 20, 2009
  • Venous Blood Clot Prevention after Hip or Knee Replacement Surgery: Bayer’s Novel Anticoagulant Rivaroxaban Submitted for Approval in the U.S. – July 30, 2008

Xarelto (rivaroxaban) FDA Approval History

Tagged with:

About author

Related Articles