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FDA Approves Novartis' Afinitor for Treating Renal Angiomyolipoma Associated ... - Genetic Engineering News

FDA granted accelerated approval to NovartisAfinitor® (everolimus) tablets for the treatment of adult patients with renal angiomyolipomas and tuberous sclerosis (TSC) complex who don’t need immediate surgery. The firm says the mTor inhibitor treatment is the first to be cleared for use in this patient population.

TSC is a genetic disorder that can cause noncancerous tumors to form in vital organs, and up to 80% of patients will develop angiomylopiomas that can lead to severe kidney damage and require surgery. Skin lesions in addition occur in over 90% of TSC patients.

U.S. approval of everolimus for the TSC and angiomyolipoma indication was based on data from the placebo-controlled Phase III Exist-2 study, which demonstrated a 42% angiomyolipoma response rate among patients treated with Afinitor compared with 0% for placebo-treated patients. Afinitor therapy also significantly prolonged time to angiomyelipoma progression. There was in addition a 26% skin lesion response rate (a 50% or more improvement) among the 97% of trial patients who presented with skin lesions.

Afinitor has previously been approved in the U.S. and other markets for the treatment of adult patients with advanced renal cell carcinoma, progressive neuroendocrine tumors of pancreatic origin, and for treating adult adn pediatric patients with subependymal giant cell astrocytoma (SEGA) associated with TSC who aren’t suitable for surgical intervention. Everolimus is in addition marketed in the U.S. and other countries under the trade names Zortress and Certican for use in the prevention of organ rejection in adult kidney and heart transplant patients.

The drug is undergoing Phase III development in combination with exemestane as a treatment for postmenopausal women with ER+Her2- advanced breast cancer.

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Home-based dialysis more popular in developing countries - News-Medical.net

Researchers at Lawson Health Research Institute have discovered that developing countries have faster growing rates of use of home-based dialysis (called peritoneal dialysis) for kidney failure than the developed world. Despite home-based dialysis' reduced cost and better outcomes, developed countries (including Canada) are using this form of therapy less.

The study by Dr. Arsh Jain, Lawson researcher and Nephrologist at London Health Sciences Centre, was published in the Journal of American Society Nephrology (JASN) last month. Peritoneal dialysis represents only 11 per cent of dialysis patients worldwide.

While the overall use of peritoneal dialysis for kidney failure is climbing world wide, rates are climbing quickly in developing countries. According to Dr. Jain, peritoneal dialysis is more cost effective than hospital-based dialysis (called hemodialysis). Dr. Jain and his colleagues analyzed records from 1997 to 2008 in 130 countries in order to come up with the conclusion that developed countries are using peritoneal dialysis less.

The study found that 59 per cent of peritoneal patients were treated in developing countries as opposed to 41 per cent in developed countries. Throughout the 12 years of the study, peritoneal dialysis patients in developing countries increased by 24.9 patients per million populations and in developed countries only 21.8 per million populations. Despite this increase the overall proportion of all dialysis patients that are treated with peritoneal dialysis in developed countries has in fact declined by 5.3 per cent, while developing countries have had no change.

"Our findings may impact future business and research innovations," said Dr. Jain. "It may be the developing world and not the developed world that drives future medical innovations in peritoneal dialysis." These results also serve as a call to action for developed countries to increase the use of this effective therapy.

Source: Lawson Health Research Institute

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Dialysis providers Fresenius, DaVita target Metro East - St. Louis Business Journal

Two of the nation’s largest dialysis providers are investing more than $6 million to open new centers in the Metro East.

Fresenius Medical Care, a Waltham, Mass.-based company that operates nearly 2,900 dialysis clinics worldwide, plans to spend $3.9 million to relocate its existing BMA Southwestern Illinois dialysis center in East Alton to a new location in Alton. Fresenius competitor DaVita Inc.    DaVita Inc. Latest from The Business Journals Briefcase Plus: Boulder environmental firm lands M Interior Dept. contractWarren Buffett says his prostate cancer is not life-threateningDaVita turns to interim CFO is seeking approval to open a $2.4 million dialysis clinic in Red Bud, Ill.

The demand for dialysis centers across the region and nationwide is on the rise. More than 26 million patients currently suffer from chronic kidney ...

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Hemodiafiltration does not improve kidney failure patients' survival or heart ... - News-Medical.net

A technique that removes additional toxins during dialysis does not improve kidney failure patients' survival or heart health, but intense treatments may provide a benefit, according to a study appearing in an upcoming issue of the Journal of the American Society Nephrology (JASN). The findings suggest that the potential of the technique, called hemodiafiltration, deserves more study.

Kidney failure patients on dialysis have a high risk of developing heart problems and dying from heart disease. Retention of certain toxins may play a role because during conventional hemodialysis, smaller substances are removed while larger toxins can accumulate in the body. A technique called hemodiafiltration, which allows for accelerated blood flow during dialysis, may help get rid of some of these toxins.

Peter Blankestijn, MD, PhD (University Medical Center Utrecht, in the Netherlands) and his colleagues looked to see if hemodiafiltration improves patients' survival and heart health compared with standard hemodialysis. Of 714 dialysis patients in the study, 358 received hemodiafiltration and 356 continued hemodialysis. "This is the largest randomized clinical trial comparing standard hemodialysis versus hemodiafiltration on meaningful clinical endpoints," said Dr. Blankestijn.

After following patients for an average of three years, the researchers found no difference between the two groups in terms of patient survival or rates of non-fatal heart problems; however, not all patients in the hemodiafiltration group received the proper dose of treatment. Patients who received the highest dose of hemodiafiltration were indeed less likely to die than those receiving hemodialysis. Additional studies are needed to confirm these findings.

Source: Journal of the American Society Nephrology

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Increasing Number of Diaverum Clinics Offer Nocturnal Haemodialysis - MarketWatch (press release)

LUND, Sweden & MUNICH, Apr 27, 2012 (BUSINESS WIRE) -- Night dialysis treatment improves both health and quality of life -- new shifts across Europe

Diaverum, one of the world's leading renal care service providers, is further expanding its service portfolio by increasing the number of dialysis clinics offering nocturnal haemodialysis. The service offers patients more flexibility to pursue a normal work and family life. In turn, the medical, social and emotional outcomes are very positive. This spring, additional nocturnal dialysis shifts have been opened in France and Portugal.

"Requiring dialysis three times a week for at least four hours is very time intensive for patients with kidney failure and demands a complete change of their daily life. We are thus constantly investigating alternatives to improve the quality of life for our patients. One of these alternatives is nocturnal dialysis," explained Dag Andersson, CEO and President of Diaverum.

With nocturnal dialysis, patients visit the clinic overnight and sleep during dialysis. They are regaining valuable time during the day while at the same time benefiting from a longer dialysis session, cleaning the blood better and improving the health of the body. The treatment time of nocturnal patients is six to eight hours instead of the standard four hours. This is less stressful for the body. Studies have shown that with a longer dialysis treatment, more toxins can be removed from the body, the patient needs less medication and can enjoy a longer, healthier life. The risk of co-morbidities can also be reduced.

Diaverum is currently offering nocturnal dialysis in selected clinics in Australia, France, Germany and Portugal treating around one per cent of Diaverum's patients. "In our clinics 'Marco de Canavezes' and 'Linda de Velha' in Portugal we have opened up new nocturnal shifts due to the large demand. It is great to see how the patients benefit from this service and how we can improve their quality of life with the extended treatment time in nocturnal dialysis," said Cesar Silva, Area Manager South West at Diaverum.

"The feedback is very positive. Many patients report after just a few weeks an improvement in their quality of life, a better general feeling and a higher physical and mental performance in their private life and at work", said Dag Andersson. "In the long run, those dialysis patients suffer from fewer complications such as cardiovascular diseases and high blood pressure."

Nocturnal dialysis is part of the holistic care approach of Diaverum which includes all forms of dialysis modalities as well as preventive care, transplantation and so called lifestyle services. These services support patients to pursue a normal life, to engage in sport or to go on a vacation without having to compromise their life-saving medical treatment.

About Diaverum

At Diaverum, our mission is to improve the quality of life for renal patients by revitalising them both physically and emotionally. Being one of the world's leading renal care providers, Diaverum offers a holistic approach, from preventive and early stage renal care to all renal replacement therapies. As a product independent provider -- the largest in Europe -- we are able to focus solely on caring for the individual needs of our patients. Our experience in renal care dates back 20 years, when the first dialysis clinic was established, previously under our former name Gambro Healthcare. Today, 6,800 employees care for more than 20,000 patients in 17 countries in Europe, Latin America, Middle East and Australia. The corporate office of Diaverum is located in Munich, Germany, the head office is in Lund, Sweden. For more information visit www.diaverum.com .

This information was brought to you by Cision http://www.cisionwire.com

SOURCE: Diaverum




        
        Diaverum 
        Ulrike Beringer 
        Director External Communication 
        E-mail: 
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        Phone: +49 (89) 45 24 44 - 124
        



Copyright Business Wire 2012

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