Intercept Pharma Canada files New Drug Submission to Health Canada for Marketing Approval of Obeticholic Acid for the Treatment of Patients with Primary Biliary Cholangitis
Obeticholic Acid represents first new treatment option for Primary Biliary Cholangitis in 20 years NEW YORK, NY, September 15, 2016 – Intercept Pharmaceuticals, Inc. (Nasdaq: ICPT), a biopharmaceutical company focused on the development and commercialization of novel therapeutics to treat non-viral, progressive liver diseases, today announced the filing of a New Drug Submission to Health Canada, seeking Canadian marketing approval for obeticholic acid (OCA) for the treatment of primary biliary cholangitis (PBC), when used in combination with ursodeoxycholic acid (UDCA)
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Mark Pruzanski, President & CEO of Intercept Pharmaceuticals. “We are pleased with Health Canada’s decision to grant OCA priority review status, recognizing the high unmet need in PBC patients, the potential of OCA to address that need, and the overall potential for significant improvements in care for these patients.
PBC is a rare, autoimmune cholestatic liver disease that puts patients at risk for life-threatening complications. PBC is primarily a disease of women, afflicting approximately one in 1,000 women over the age of 40; in Canada, this equates to roughly 8,000 cases across the country. If left untreated, survival of PBC patients is significantly worse than the general population.
Canadian expertise has played a significant role in driving both clinical research and advances in PBC care. With nine clinical trial sites across the country for PBC treatment, Canadian clinicians, patients and health institutions have been instrumental in PBC-related developments, including overall disease awareness and the development of
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Andrew Mason, Director of Research for the Division of Gastroenterology and Hepatology at the University of Alberta. “In the last few years, we’ve made a lot of progress in both understanding PBC and ensuring proper care for patients. With continued research and an emphasis on putting patients first, we look forward to the day where all PBC patients can truly manage their condition.
While Health Canada reviews the New Drug Submission, Intercept looks forward to engaging in Canada’s Common Drug Review process in parallel to enable access to Canadian PBC patients as soon as possible following potential regulatory approval.
In May 2016, OCA received accelerated approval from the US Food and Drug Administration and is currently under review with the European Medicines Agency (EMA).
About Obeticholic Acid (OCA)
Ocaliva is an agonist for FXR, a nuclear receptor expressed in the liver and intestine. FXR is a key regulator of bile acid, inflammatory, fibrotic, and metabolic pathways. If approved, OCA will offer an important new treatment option for the substantial number of patients who have an inadequate response to UDCA and are consequently at increased risk of liver failure, need for liver transplantation, or
D1: I have decided to look at a 6 year old going through bereavement. Bereavement means to lose an individual very close to you. When children go through bereavement they are most likely to feel sad and upset about the person’s death. Children at a young age may not understand when a family member dies. Children may not understand bereavement. For example a 6 year old’s father been in a car crash and has died from that incident. Death is unpredictable and children can’t be prepared for a death of a family member as no one knows when someone is going to die or not. Unfortunately every child can experience bereavement even when a pet dies. It is important that we are aware that effects on the child so we can support them in the aftermath.
Omnicare has a direct impact on the health of senior citizens. They should also continue in this area. They can leverage their pharmaceutical expertise to create unique databases and proprietary clinical information services, all focused on providing the safest, most appropriate, most cost-effective drug therapies for the elderly. Their programs and services encourage early diagnosis and treatment, since this usually provides the best quality of life at a lower cost.
What does ‘care’ mean? Care is the provision of what is necessary for your health, welfare and protection of someone or something. However when you talk about ‘care’ in a care practice the term changes and becomes more about enabling people to meet all their needs which would refer to their social, physical, emotional, cognitive and cultural needs. The individual is central to the meaning of care in this context.
Canada’s health care system is one of the top in the world; due to the federal legislation for publicly funded health care insurance. Requiring provinces and territories to follow certain conditions and guidelines to maintain universal health care, which is known as the Canada Health Act passed in 1984. There are five main principles within the Canada Health Act; public administrations, comprehensiveness, universality, accessibility, and portability. Moreover there are three aspects within the principles, equity, access and undeserved. Several marginalized populations do not receive the adequate health care even though the Canada Health Act is in place to help “protect, promote and restore the physical and mental well-being of residents of
2.3 Explain how the health and social care practitioner own values, beliefs and experiences can influence delivery of care.
This report has been written to explore what the context of healthy communities is. The defined community will be introduced and a geographical map included. Gathered information of the specified community will be evaluated, data’s and statistics will be presented in tables. The focus will be on the health and social care needs of that community. Viewpoints of the residents of the chosen community will be summarized and discussed. Recommendation about observed issues will be implemented. Furthermore, theories and sociological aspects of diverse authors regarding notion communities will be included as they can support the findings.
Hepatitis B is a DNA viral infection that causes damage and inflammation to the liver. It was first discovered in 1965 by Dr. Baruch Blumberg. The HBV virus is very contagious and is even thought to be the most serious form of viral hepatitis and the most common viral infection on Earth. “HBV is 100 times more infectious than HIV.” (Green, 2002, pg. 7) The virus can survive for about one week outside the body on a dry surface. According to Green (2002, pg. 7), “One in twenty Americans has been infected with the virus at some point in their lives.” Between the ages of 15-39 is when 75% of new HBV infections occur, according to Green (2002, pg.8).
Ostrove, N. M. (2004). Statement of Nancy M. Ostrove, Ph.D., Deputy Director, Division of Drug.
Omeprazole belongs to the family of medications called proton pump inhibitors (PPIs). It slows or prevents the production of acid within the stomach and is used to treat conditions where reduction in acid secretion is required for proper healing including stomach and intestinal ulcers (gastric and duodenal ulcers), the prevention and treatment of ulcers associated with medications known as NSAIDs, reflux oesophagitis, Zollinger-Ellison syndrome, heartburn, and gastro oesophageal reflux disease (GERD). Omeprazole, like other proton-pump inhibitors, blocks the enzyme in the wall of the stomach that produces acid. By blocking the enzyme, the production of acid is decreased, and this allows the stomach and oesophagus to heal. This essay will discuss the therapeutic effect and uses of Omeprazole, its mechanism of action, administration and dosage, dose-related and non-d...
The healthcare system in Canada is funded largely by the federal government as determined by the constitution. However, the actual healthcare delivery and social services is left up to each province and territory. Each province has the power to pass legislation that governs the financing and delivery of healthcare services to Canadians residing in that province. This fact encourages all healthcare professionals who have a strong provincial association and want to advocate their position on healthcare to speak up, if they want something different. If a physician wants to start delivery of telemedicine to rural areas of the province, he or she can advocate their position and
Turner, B. J., Newschaffer, C. J., Zhang, D., Fanning, T., & Hauck, W. W. (1999). Translating clinical trial results into practice. Annals of Internal Medicine, 130(12), 979-986.
A health care system exists to address the health care issues of its community. To do so equitably it must recognise, plan for and implement necessary changes to cater for the diverse needs of the community. It is when the community engages in dialogue with the providers of health care that the specific needs are revealed and can then be planned for and implemented. However it is often those who have no voice in the community who have the greatest need of health care. Their lower socio economic status, as well as their lower educational levels, deters them from accessing appropriate health care. Consumer participation is one way to address this lack of representation.
Physician Vol. 47.10 (2001): 2037-2042. The College of Family Physicians of Canada. Web. 30 March 2014.
Education is neither linear nor static. It requires evolution and fluctuations. I received my undergraduate degree in Exercise Science at UNC Charlotte, and now it is time for a prime conversion to be made. Attending the Masters of Public Health program at UNC Charlotte would open the door for me to pursue my career aspirations in health care. Specifically, I am interested in epidemiological methods in community health. My ambition, perseverance, and work ethic have brought me to a high point, and enrolling in the Masters in Public Health program would raise that threshold even higher.
Health care has always been an interesting topic all over the world. Voltaire once said, “The art of medicine consists of amusing the patient while nature cures the disease.” It may seem like health care that nothing gets accomplished in different health care systems, but ultimately many trying to cures diseases and improve health care systems.