JOHNSON & JOHNSON
The Janssen Pharmaceutical Companies of
The NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE, or blood clots) and reduction in the risk of recurrent VTE in patients aged birth to less than 18 years of age after at least five days of initial parenteral anticoagulant treatment and thromboprophylaxis (prevention of blood clots) in patients aged 2 years and older with congenital heart disease who have undergone the Fontan procedure. If approved, XARELTO will be the first and only oral Factor Xa inhibitor indicated in the
CLICK TO TWEET: @JanssenUS announces NDA submission to @US_FDA for two new potential pediatric indications for the treatment and prevention of #bloodclots. Learn more: https://ctt.ac/dS3qz+
Current guidelines are limited and recommend treating pediatric patients with or at risk for reoccurring blood clots with standard anticoagulant therapy, which often requires painful injections, dietary restrictions and regular laboratory monitoring. There are currently no FDA-approved anticoagulation therapies for pediatric patients with congenital heart disease who have undergone the Fontan procedure, a surgical procedure that redirects blood flow from the lower body to the lungs. The limited guidance for managing these patients leaves physicians to extrapolate adult data to infer pediatric dosing and then regularly monitor their patients.
'The filing of this application is an important step in helping to address the burden of blood clots and provide doctors with optimal body weight-based dosing options in pediatric patients,' said
The application is based on evidence from adequate and well-controlled studies of XARELTO in adults as well as data from two Phase 3 clinical trials of XARELTO in pediatric populations: EINSTEIN-Jr, which examined pediatric patients with previously diagnosed VTE, and UNIVERSE, which evaluated pediatric patients who are at risk of VTE after recently undergoing the Fontan procedure.
Part of the industry leading EXPLORER clinical research program, EINSTEIN-Jr is the largest study completed to date evaluating the treatment of pediatric patients with VTE, and UNIVERSE is the first clinical trial to examine a DOAC for the prevention of thromboembolism in congenital heart disease post-Fontan pediatric patients.
For both potential indications, XARELTO would be dosed based on body weight, either with an oral suspension formulation or tablets. The oral suspension formulation would be administered through a unique color-coded dosing device that was designed to help minimize dosing errors.
Earlier this year, Janssen's development partner Bayer received approval in
About EINSTEIN-Jr EINSTEIN-Jr is a randomized, multicenter, active-controlled, open-label Phase 3 study that evaluated the use of XARELTO in 500 children, aged birth to 17 years, with previously diagnosed acute VTE who had started parenteral anticoagulation therapy. Participants were enrolled from
About UNIVERSE
UNIVERSE is a randomized, multicenter, open-label, active controlled, two-part, Phase 3 study that examined the use of a novel, oral suspension XARELTO formulation in children 2-8 years old with single ventricle physiology who had the Fontan procedure within four months before enrollment. From
UNIVERSE was conducted in two parts. Part A evaluated the single- and multiple-dose PK and PD properties of XARELTO while Part B evaluated the comparative safety and efficacy of XARELTO versus aspirin when used for thromboprophylaxis for 12 months.
About EXPLORER
The EXPLORER clinical research 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. 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. Since its inception, the program has built upon extensive evidence reinforcing the benefits of XARELTO for the millions of patients to whom it has been prescribed since its launch in 2011.
WHAT IS XARELTO (rivaroxaban)
XARELTO is a prescription medicine used to: reduce the risk of stroke and blood clots in people who have a medical condition called atrial fibrillation that is not caused by a heart valve problem. With atrial fibrillation, part of the heart does not beat the way it should. This can lead to the formation of blood clots, which can travel to the brain, causing a stroke, or to other parts of the body treat blood clots in the veins of your legs (deep vein thrombosis or DVT) or lungs (pulmonary embolism or PE) reduce the risk of blood clots happening again in people who continue to be at risk for DVT or PE after receiving treatment for blood clots for at least 6 months help prevent a blood clot in the legs and lungs of people who have just had hip or knee replacement surgery help prevent blood clots in certain people hospitalized for an acute illness and after discharge, who are at risk of getting blood clots because of the loss of or decreased ability to move around (mobility) and other risks for getting blood clots, and who do not have a high risk of bleeding XARELTO is used with low dose aspirin to: reduce the risk of serious heart problems, heart attack and stroke in people with coronary artery disease (a condition where the blood supply to the heart is reduced or blocked) or peripheral artery disease (a condition where the blood flow to the legs is reduced) It is not known if XARELTO is safe and effective in children.
IMPORTANT SAFETY INFORMATION
WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT XARELTO
XARELTO may cause serious side effects, including: Increased risk of blood clots if you stop taking XARELTO. People with atrial fibrillation (an irregular heart beat) that is not caused by a heart valve problem (nonvalvular) are at an increased risk of forming a blood clot in the heart, which can travel to the brain, causing a stroke, or to other parts of the body. XARELTO lowers your chance of having a stroke by helping to prevent clots from forming. If you stop taking XARELTO, you may have increased risk of forming a clot in your blood.
Do not stop taking XARELTO without talking to the doctor who prescribes it for you. Stopping XARELTO increases your risk of having a stroke. If you have to stop taking XARELTO, your doctor may prescribe another blood thinner medicine to prevent a blood clot from forming.
Increased risk of bleeding. XARELTO can cause bleeding which can be serious, and may lead to death. This is because XARELTO is a blood thinner medicine (anticoagulant) that lowers blood clotting. During treatment with XARELTO you are likely to bruise more easily, and it may take longer for bleeding to stop. You may be at higher risk of bleeding if you take XARELTO and have certain other medical problems.
You may have a higher risk of bleeding if you take XARELTO and take other medicines that increase your risk of bleeding, including:
Aspirin or aspirin-containing products
Long-term (chronic) use of non-steroidal anti-inflammatory drugs (NSAIDs)
Warfarin sodium (Coumadin, Jantoven)
Any medicine that contains heparin
Clopidogrel (Plavix)
Selective serotonin reuptake inhibitors (SSRIs) or serotonin norepinephrine reuptake inhibitors (SNRIs)
Other medicines to prevent or treat blood clots
Tell your doctor if you take any of these medicines. Ask your doctor or pharmacist if you are not sure if your medicine is one listed above.
Call your doctor or get medical help right away if you develop any of these signs or symptoms of bleeding: Unexpected bleeding or bleeding that lasts a long time, such as: Nosebleeds that happen often
Unusual bleeding from gums
Menstrual bleeding that is heavier than normal, or vaginal bleeding
Bleeding that is severe or you cannot control
Red, pink, or brown urine
Bright red or black stools (looks like tar)
Cough up blood or blood clots
Vomit blood or your vomit looks like 'coffee grounds'
Headaches, feeling dizzy or weak
Pain, swelling, or new drainage at wound sites
Spinal or epidural blood clots (hematoma). People who take a blood thinner medicine (anticoagulant) like XARELTO, and have medicine injected into their spinal and epidural area, or have a spinal puncture, have a risk of forming a blood clot that can cause long-term or permanent loss of the ability to move (paralysis). Your risk of developing a spinal or epidural blood clot is higher if:
A thin tube called an epidural catheter is placed in your back to give you certain medicine
You take NSAIDs or a medicine to prevent blood from clotting
You have a history of difficult or repeated epidural or spinal punctures
You have a history of problems with your spine or have had surgery on your spine
If you take XARELTO and receive spinal anesthesia or have a spinal puncture, your doctor should watch you closely for symptoms of spinal or epidural blood clots. Tell your doctor right away if you have back pain, tingling, numbness, muscle weak
About Janssen Cardiovascular & Metabolism
In Cardiovascular & Metabolism (CVM), we take on the most pervasive diseases that burden hundreds of millions of people and healthcare systems around the world. As part of this long-standing commitment and propelled by our successes in treating type 2 diabetes and thrombosis, we advance highly differentiated therapies that prevent and treat life-threatening cardiovascular, metabolic and retinal diseases. Uncovering new therapies that can improve the quality of life for this large segment of the population is an important endeavor - one which Janssen CVM will continue to lead in the years to come. Our mission is global, local and personal. Together, we can reshape the future of cardiovascular, metabolic and retinal disease prevention and treatment.
About the Janssen Pharmaceutical Companies of
At Janssen, we're creating a future where disease is a thing of the past. We're the Pharmaceutical Companies of
Learn more at www.janssen.com. Follow us at www.twitter.com/JanssenUS and https://twitter.com/JanssenGlobal.
Cautions Concerning Forward-Looking Statements
This press release contains 'forward-looking statements' as defined in the Private Securities Litigation Reform Act of 1995 regarding 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
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