Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 10-13 December 2012

London, UK (December 14, 2012) - This page provides an overview of the opinions adopted at the December 2012 meeting of the CHMP and other important outcomes. In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures.

To review the individual press releases, question-and-answer documents and other documents, please click on the links under ‘more information’. The Agency publishes a new page following the CHMP meeting each month.

Positive recommendations on new medicines

Selincro offers treatment in conjunction with psychosocial support

EMA recommends approval of medicine for reduction of alcohol consumption

London, UK (December 14, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Selincro, a medicinal product intended for the reduction of alcohol consumption in adults with alcohol dependence.

Updated advice to reduce risk of gas embolism during spray application

EMA recommends new advice on safer use of fibrin sealant spray applications

London, UK (December 14, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of new instructions for healthcare professionals using the fibrin sealants Tisseel, Tissucol, Artiss and Beriplast P (and associated names) to optimise the safe use of these medicines when applied as spray during surgery.

FDA approves Iclusig to treat two rare types of leukemia

Silver Spring, MD, USA (December 14, 2012) - The U.S. Food and Drug Administration today approved Iclusig (ponatinib) to treat adults with chronic myeloid leukemia (CML) and Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL), two rare blood and bone marrow diseases.

FDA approves raxibacumab to treat inhalational anthrax

Silver Spring (December 14, 2012) - The U.S. Food and Drug Administration today approved raxibacumab injection to treat inhalational anthrax, a form of the infectious disease caused by breathing in the spores of the bacterium Bacillus anthracis. Raxibacumab also is approved to prevent inhalational anthrax when alternative therapies are not available or not appropriate.

Drug can now be used before treatment with chemotherapy

FDA expands Zytiga’s use for late-stage prostate cancer

Silver Spring, MD, USA (December 10, 2012) - The U.S. Food and Drug Administration today expanded the approved use of Zytiga (abiraterone acetate) to treat men with late-stage (metastatic) castration-resistant prostate cancer prior to receiving chemotherapy.

Sharp spike in computer-related injuries predicted for medical workers

ITHACA, N.Y. (December 3, 2012) – As U.S. health care goes high tech, spurred by $20 billion in federal stimulus incentives, the widespread adoption of electronic medical records and related digital technologies is predicted to reduce errors and lower costs – but it is also likely to significantly boost musculoskeletal injuries among doctors and nurses, concludes a Cornell University ergonomics professor in two new papers.

NICE recommends depth of anaesthesia monitors

London, UK, (November 21, 2012) - Healthcare guidance body NICE has today (21 November) published final guidance recommending the use of the Bispectral Index (BIS, Covidien), E-Entropy (GE Healthcare) and Narcotrend-Compact M (MT MonitorTechnik GmbH & Co) EEG-based depth of anaesthesia monitors as options in patients receiving total intravenous anaesthesia and in patients who are considered at higher risk of adverse outcomes during any type of general anaesthesia. This includes patients who are at higher risk of unintended awareness and patients who are at higher risk from excessively deep anaesthesia.

Alcohol provides protective effect, reduces mortality substantial

Chicago, Ill., USA (November 19, 2012) - Injured patients were less likely to die in the hospital if they had alcohol in their blood, according to a study from the University of Illinois at Chicago School of Public Health -- and the more alcohol, the more likely they were to survive. "This study is not encouraging people to drink," cautions UIC injury epidemiologist Lee Friedman, author of the study, which will be published in the December issue of the journal Alcohol and is now online. That's because alcohol intoxication -- even minor inebriation -- is associated with an increased risk of being injured, he says.

EMA Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 12-15 November 2012

London (November 16, 2012) - This page provides an overview of the opinions adopted at the November 2012 meeting of the CHMP and other important outcomes.
In the table below, readers can view the main opinions adopted at the meeting, as well as information on referral procedures. To review the individual press releases, question-and-answer documents and other documents, please click on the links under ‘more information’.

The Agency publishes a new page following the CHMP meeting each month.

New measures to minimise the risk of gas embolism during spray application

European Medicines Agency recommends new advice to surgeons on safer use of fibrin sealants Evicel and Quixil

London (November 16, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended a number of risk-minimisation measures for the fibrin sealants Evicel and Quixil to minimise the risk of gas embolism when these medicines are applied as spray during surgery.

EMA recommends approval of first vaccine for meningitis B

Vaccine to provide broad coverage against meningococcal group B infections

London (November 16, 2012) - The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the granting of a marketing authorisation for Bexsero, a new vaccine intended for the immunisation of individuals over two months of age against invasive meningococcal disease caused by Neisseria meningitidis group B. There is currently no authorised vaccine available in the European Union (EU) for bacterial meningitis caused by Neisseria meningitidis group B.

Advocacy for planned home birth not in patients' best interest

• Home-birth-like experience in hospitals ultimately safer, more satisfying, and more cost effective for patients

Philadelphia, PA (November 13, 2012) – Advocates of planned home birth have emphasized its benefits for patient safety, patient satisfaction, cost effectiveness, and respect for women's rights. A clinical opinion paper published in the American Journal of Obstetrics and Gynecology critically evaluates each of these claims in its effort to identify professionally appropriate responses of obstetricians and other concerned physicians to planned home birth.

Xarelto® (Rivaroxaban)

Landmark Phase III Study of Bayer’s Xarelto® (Rivaroxaban) Initiated for the Secondary Prevention of Myocardial Infarction and Death in Patients with Coronary or Peripheral Artery Disease

• 20,000-patient study will be conducted in collaboration with Population Health Research Institute
• Composite of cardiovascular death, myocardial infarction and stroke as primary efficacy endpoint
• Rivaroxaban is the first novel oral anticoagulant under assessment in this high risk patient population

Berlin, Germany (November 13, 2012) – Bayer HealthCare announced today the initiation of the COMPASS study, the largest clinical study of its oral anticoagulant Xarelto® (rivaroxaban) to date, investigating the prevention of major adverse cardiac events (MACE) including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease (CAD) or peripheral artery disease (PAD).

The Phase III study COMPASS will assess the potential of rivaroxaban to provide important additional protection to patients when added to aspirin as compared to rivaroxaban and aspirin as single treatments. The study will be conducted in collaboration with the Population Health Research Institute (PHRI) and will enroll approximately 20,000 patients from more than 450 sites across more than 25 countries worldwide.

“Today, aspirin is the gold standard and provides significant protection for patients with coronary or peripheral artery disease. However, a residual risk of cardiac events such as heart attack, stroke or even death remains in these high-risk patients,” said Dr. Salim Yusuf, Executive Director of the PHRI, Canada, and Principal Investigator of the COMPASS study. “This is therefore an important study, designed to provide significant insights on additional, potentially complementary, cardioprotective benefits of rivaroxaban for these patients.”

In CAD and PAD, the inner wall of the arteries progressively thickens due to accumulation of lipids, calcification and cell proliferation. This plaque narrows the arteries and decreases the amount of blood flow to the heart muscle or the legs. This process is called atherosclerosis. If plaque from the wall of an artery ruptures, a blood clot can form at the site of the rupture leading to serious events including myocardial infarction, stroke or even death.

Currently, the most commonly prescribed treatments for the prevention of MACE in CAD and PAD patients are antiplatelet agents such as aspirin – a product with a well documented role in the prevention of cardiovascular events across a broad range of patients.

“Antiplatelet therapies and rivaroxaban have complementary mechanisms of action and when combined have been shown to improve outcomes in patients with acute coronary syndrome. In the same way, COMPASS will evaluate whether the combination has the potential for more complete protection against long-term clot formation in patients with CAD and PAD in comparison to each of the products alone,” said Dr. Kemal Malik, Member of the Bayer HealthCare Executive Committee and Head of Global Development.

About the Burden of Coronary and Peripheral Artery Disease

Coronary artery disease (CAD) is the most common cause of cardiovascular disease and is responsible for approximately 7.3 million deaths worldwide every year. One-third to one-half of all middle-aged men and women in high income countries are at risk of developing CAD during their lifetime, and the number of people with CAD is rising globally. By 2020, the burden of coronary artery disease is projected to reach 82 million disability-adjusted life years (DALYs) or “healthy years of life lost”.

Peripheral artery disease (PAD), while often undiagnosed, affects over 27 million people in Europe and North America and is a powerful risk marker of cardiovascular disease. Globally, screening studies suggest that approximately 20% of adults older than 55 years have evidence of PAD. The disease prevalence is strongly age-related and, like CAD, the numbers of affected patients is rising, because of the aging of the population.

About COMPASS

The Phase III study COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) will include approximately 20,000 patients from more than 450 sites across more than 25 countries worldwide. Patients with documented atherosclerosis related to CAD or PAD will be enrolled into the study. The primary efficacy endpoint is a composite of cardiovascular death, myocardial infarction and stroke. The primary safety endpoint is major bleeding. In the study, patients will be randomized to receive either rivaroxaban 2.5 mg twice-daily in addition to aspirin 100 mg once-daily, rivaroxaban 5 mg twice-daily alone, or aspirin 100 mg once-daily alone. The study will be conducted by the Population Health Research Institute (PHRI), a leading academic health science research organization based in Hamilton, Ontario, Canada.

About the Population Health Research Institute (PHRI)

PHRI is a world-leading academic health science research institute focused on improving global health outcomes. Based in Hamilton, Ontario, Canada, its research interests are global and include a broad spectrum of health-related issues. Originally a cardiovascular disease research institute, PHRI's programmes have expanded to include a broad range of medical and societal conditions in varied populations defined by ethnicity and/or geographic region. To date, PHRI has conducted more than 50 global trials and epidemiological studies in more than 1,500 centres in 83 countries, involving over 500,000 patients. More information can be found at www.phri.ca

About Venous Arterial Thromboembolism (VAT)

Thrombosis is the formation of a blood clot inside a blood vessel, blocking a vein (venous thrombosis) or artery (arterial thrombosis). Venous Arterial Thromboembolism (VAT) is caused when some or all of a clot detaches and is moved within the blood stream until it obstructs a smaller vessel. This can result in damage to vital organs, because the tissue beyond the blockage no longer receives nutrients and oxygen.

VAT is responsible for a number of serious and life threatening conditions:

• Venous Thromboembolism (VTE) occurs when part of a clot formed in a deep vein, for example in the leg (known as deep vein thrombosis, or DVT), is carried to the lung, via the heart, preventing the uptake of oxygen. This is known as a pulmonary embolism (PE), an event which can be rapidly fatal
• Arterial Thromboembolism occurs when oxygenated blood flow from the heart to another part of the body (via an artery) is interrupted by a blood clot. If this occurs in a vessel supplying blood to the brain, it can lead to a stroke, an event that can be severely debilitating or fatal. If it occurs in a coronary artery, it can lead to acute coronary syndrome (ACS), a complication of coronary heart disease which includes conditions such as myocardial infarction (heart attack), and unstable angina

VAT is responsible for significant morbidity and mortality, and requires active or preventative treatment to avoid potentially serious or fatal patient outcomes.

To learn more about VAT, please visit www.VATspace.com

About Xarelto® (Rivaroxaban)

Rivaroxaban is the most broadly indicated new oral anticoagulant and is marketed under the brand name Xarelto®. To date, Xarelto is approved for use in the following venous arterial thromboembolic (VAT) indications:

• The prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (AF) with one or more risk factors in more than 70 countries worldwide
• The treatment of deep vein thrombosis (DVT) and prevention of recurrent DVT and pulmonary embolism (PE) in adults in more than 70 countries worldwide
• In the U.S. also for the treatment of pulmonary embolism and prevention of recurrent PE and DVT in adults
• The prevention of venous thromboembolism (VTE) in adult patients undergoing elective hip or knee replacement surgery in more than 120 countries worldwide

Since the first approval of Xarelto in 2008, more than two and a half million patients worldwide have now received Xarelto in daily clinical practice.

Rivaroxaban was discovered by Bayer HealthCare, and is being jointly developed with Janssen Research & Development, LLC. Xarelto is marketed outside the U.S. by Bayer HealthCare and in the U.S. by Janssen Pharmaceuticals, Inc. (a Johnson & Johnson Company).

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 high priority for Bayer, and the company has developed a Prescribers Guide for physicians and a Xarelto Patient Card for patients to support best practices.

• To learn more, please visit: https://prescribe.xarelto.com
• To learn more about thrombosis, please visit www.thrombosisadviser.com
• To learn more about Xarelto, please visit www.xarelto.com

About Aspirin®

Acetylsalicylic acid, the active ingredient in Aspirin®, has been extensively investigated in more than 200 studies involving more than 200,000 patients across varying levels of cardiovascular (CV) risk. Given the existing body of clinical evidence, low-dose aspirin use in appropriate patients is approved by regulatory authorities around the world for CV event prevention, and supported by major evidence-based clinical guidelines, including those of the American Heart Association and American College of Cardiology, European Society of Cardiology, and American College of Chest Physicians.

Based on its proven efficacy, safety and cost-effectiveness, low-dose aspirin continues to be the standard of care for reducing heart attacks and ischemic strokes in patients with established CV disease. Additionally, in more than 50 countries around the world, lowdose aspirin is approved for use in the primary prevention of CV events in appropriate at risk patients. When used as directed by a physician, low-dose aspirin is infrequently associated with clinically significant side effects. Serious bleeding rarely occurs. Gastrointestinal bleeding (GI) has been shown to occur in less than 1% of those taking aspirin to prevent a recurrent CV event; serious GI or extracranial bleeding events are expected in less than 1/10th of one percent (3 in 10,000 people per year) patients taking low-dose aspirin for primary prevention1. Bayer supports the use of aspirin for primary prevention only in those markets where the indications have been approved.

Annotation 

1 Antithrombotic Trialists’ (ATT) Collaboration. Aspirin in the primary and secondary prevention of vascular disease: collaborative meta-analysis of individual participant data from randomised clinical trials. The Lancet 2009; 373:1849-1860

About Bayer HealthCare

The Bayer Group is a global enterprise with core competencies in the fields of health care, agriculture and high-tech materials. Bayer HealthCare, a subgroup of Bayer AG with annual sales of EUR 17.2 billion (2011), is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany. The company combines the global activities of the Animal Health, Consumer Care, Medical Care and Pharmaceuticals divisions. Bayer HealthCare’s aim is to discover, develop, manufacture and market products that will improve human and animal health worldwide. Bayer HealthCare has a global workforce of 55,700 employees (Dec 31, 2011) and is represented in more than 100 countries. More information at www.healthcare.bayer.com

Bayer HealthCare, 13.11.2012 (tB).

Patients shy away from asking healthcare workers to wash hands

Patient empowerment seen as possible tool to raise hand hygiene behaviors

Chicago, Ill., USA (November 12, 2012) – According to a new study published online today, most patients at risk for healthcare-associated infections (HAIs) agree that healthcare workers should be reminded to wash their hands, but little more than half would feel comfortable asking their physicians to wash. The study is published in the December issue of Infection Control and Hospital Epidemiology, the journal of the Society for Healthcare Epidemiology of America. The study points to the need for patient empowerment to improve hand hygiene of healthcare workers.

FDA approves Xeljanz for rheumatoid arthritis

Silver Spring, MD, USA (November 6, 2012) - The U.S. Food and Drug Administration today approved Xeljanz (tofacitinib) to treat adults with moderately to severely active rheumatoid arthritis (RA) who have had an inadequate response to, or who are intolerant of, methotrexate.

National Senior Safety Week – Drug safety for seniors

Is your memory playing tricks on you? Check your medicine cabinet!

Montreal, Canada (November 6, 2012) - Common medication to treat insomnia, anxiety, itching or allergies can have a negative impact on memory or concentration in the elderly, according to Dr. Cara Tannenbaum, Research Chair at the Institut universitaire de gériatrie de Montréal (IUGM, Montreal Geriatric University Institute) and Associate Professor of Medicine and Pharmacy at the University of Montreal (UdeM). Up to ninety percent of people over the age of 65 take at least one prescription medication. Eighteen percent of people in this age group complain of memory problems and are found to have mild cognitive deficits. Research suggests there may be a link between the two.

Drug doesn't significantly lower risk of major heart problems in dialysis patients

Stanford, CA, USA (November 5, 2012) - In one of the largest and longest trials involving patients with kidney failure, a study led by an international team of researchers found that cinacalcet — a drug commonly prescribed to patients with kidney failure and a disturbance of bone and mineral metabolism known as secondary hyperparathyroidism — does not significantly reduce the risk of death or major cardiovascular events.

FDA expands use of Xarelto to treat, reduce recurrence of blood clots

Silver Spring, MD, USA (November 2, 2012) - The U.S. Food and Drug Administration today expanded the approved use of Xarelto (rivaroxaban) to include treating deep vein thrombosis (DVT) or pulmonary embolism (PE), and to reduce the risk of recurrent DVT and PE following initial treatment.

Study suggests too much risk associated with SSRI usage and pregnancy

Antidepressants should only be prescribed with great caution

Boston, MA, USA (October 31, 2012) – Elevated risk of miscarriage, preterm birth, neonatal health complications and possible longer term neurobehavioral abnormalities, including autism, suggest that a class of antidepressants known as selective serotonin reuptake inhibitors (SSRI) should only be prescribed with great caution and with full counseling for women experiencing depression and attempting to get pregnant, say researchers at Beth Israel Deaconess Medical Center, Tufts Medical Center and MetroWest Medical Center.

Researchers invent a quick-release medical tape that minimizes neonatal skin injury

No more tears from tears

Boston, MA, USA (October 29, 2012) — Commercial medical tapes on the market today are great at keeping medical devices attached to the skin, but often can do damage—such as skin tissue tearing—once it's time to remove them. A research team from Brigham and Women's Hospital (BWH) has invented a quick-release tape that has the strong adhesion properties of commercial medical tape, but without the ouch factor upon removal.

The team was led by Jeffrey Karp, PhD, BWH Division of Biomedical Engineering, Department of Medicine, senior study author in collaboration with The Institute for Pediatric Innovation which defined the need and requirements for a new neonatal adhesive based on national surveys of neonatal clinicians.

Hot flashes can come back after SSRI

Cleveland, Ohio, USA (October 24, 2012) - Hot flashes and night sweats can return after women stop using escitalopram—an antidepressant—to treat these menopause symptoms, according to a study published online this month in Menopause, the journal of the North American Menopause Society. This is typical of stopping hormone therapy as well.

Can Diabetes Devices be Damaged by Airport Security Scanners?

New Rochelle, NY(October 24, 2012) — Full-body or X-ray scanners used for airport security screening may affect the function of insulin pump or continuous glucose monitoring (CGM) devices. People with diabetes can present a travel letter obtained from their physicians to avoid possible damage caused by exposure to imaging equipment in airports. The risk to these sensitive devices posed by scanners and the low-pressure conditions on airplanes are the focus of the Editorial “Navigating Airport Security with an Insulin Pump and/or Sensor,” published in Diabetes Technology & Therapeutics, a peer-reviewed journal from Mary Ann Liebert, Inc., publishers. The Editorial is available free on the Diabetes Technology & Therapeutics website.

Results of the TRILOGY ACS Angiographic Cohort presented at TCT 2012

Study finds that prasugrel may reduce cardiovascular events among patients managed medically after an angiogram for acute coronary syndrome

Miami, FL, USA (October 24, 2012) – A study has found that the anti-clotting medication prasugrel reduced cardiovascular events among patients who present with an acute coronary syndrome and are managed medically after an angiogram is performed to determine coronary anatomy. Results of the TRILOGY ACS trial, Angiographic Cohort were presented today at the 24th annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium. Sponsored by the Cardiovascular Research Foundation (CRF), TCT is the world's premier educational meeting specializing in interventional cardiovascular medicine.

Challenging Parkinson's dogma

Boston, MA, USA (October 24, 2012) - Scientists may have discovered why the standard treatment for Parkinson's disease is often effective for only a limited period of time. Their research could lead to a better understanding of many brain disorders, from drug addiction to depression, that share certain signaling molecules involved in modulating brain activity.