Launch By Menarini And Ipsen Of ADENURIC R febuxostat In France For The Treatment Of Chronic Hyperuricemia In Gout
Ipsen (Paris:IPN) (Euronext: FR0010259150; IPN), a global biotechnology specialty care group and Menarini, the first Italian pharmaceutical Group in the world with a significant pan-European presence, announced the launch of ADENURIC® (febuxostat) in France where they will co-promote the drug. Other launches by Menarini are planned shortly, notably in United Kingdom, Germany and Ireland. Thierry Poiraud, MD, General Manager, Menarini France said: "We are proud to be the first country in Europe to launch this very promising drug with Ipsen. In collaboration with rheumatologists and general practitioners I hope we can significantly improve the chronic management of this painful and frequent disease, which may lead to serious complications with a major impact on quality of life.
A medical imaging technique called dual-energy computed tomography (CT) is an effective and reliable way to diagnose gout in the acute, emergency setting, according to a study published in the April issue of the American Journal of Roentgenology. Dual-energy CT is an advanced medical imaging technique that can detect vessels and bones and display them in clear contrast to one another. It enables physicians to diagnose many patients' conditions faster and more accurately as it can better characterize tissue composition better than conventional CT. Gout is an extremely painful kind of arthritis that occurs when uric acid builds up in and around the joints. "Doctors often use clinical features to diagnose gout, however many other diseases can mimic or coexist with it and conventional imaging techniques like X-rays, ultrasound, and conventional CT are not specific enough to facilitate a diagnosis, " said Savvakis Nicolaou, MD, lead author of the study.
Researchers from the ETH Zurich's Department of Biosystems Science and Engineering (D-BSSE) have devised a new method for preventing and permanently eradicating the cause of gout. It involves implanting a biological network that regulates the uric acid levels autonomously. As Paracelsus once stated, the dose makes the poison. This not only goes for chemical substances introduced to the body, but also those produced by it. The uric acid in the blood especially needs to be in the proper dosage. If the level is too high (i.e. above 6.8 mg/dl blood), the uric acid crystallizes out, which can cause kidney stones and gout. However, uric acid is an important part of the human detoxification system, acting as a so-called "scavenger" of free radicals, which cause neurological disorders, brain diseases and tumors.
Researchers from Boston University School of Medicine found that women with serum uric acid levels over 5 mg/dl had a significantly lower risk of developing gout than men. This study, the first to examine the relationship between uric acid levels and gout risk in women, also evaluated purported risk factors for gout and found that increasing age, obesity, hypertension, alcohol use, and diuretic use to be among leading contributors for women. Results of this 52-year follow-up study are published in the April issue of Arthritis & Rheumatism, a journal of the American College of Rheumatology. Gout is a common and excruciatingly painful inflammatory arthritis caused by elevated uric acid levels in the blood. When too much uric acid builds up in joint fluid, uric acid crystals form and cause joint swelling and inflammation.
Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) announced that the U.S. Food and Drug Administration (FDA) has acknowledged receipt of and accepted for review the March 15, 2010 resubmission of the Biologics License Application (BLA) for KRYSTEXXA ™ (pegloticase), a treatment for chronic gout in patients refractory to conventional therapy. The FDA has deemed the resubmission a complete, class 2 response and has established September 14, 2010 as the PDUFA action date. The FDA also acknowledged that the BLA resubmission contains additional chemistry, manufacturing and controls (CMC), Safety Update, Labeling, Risk Evaluation and Mitigation Strategy (REMS) and Medication Guide submitted in response to the FDA's July 31, 2009 complete response letter. "As expected, the FDA has determined our resubmission to be a class 2 review matter and thus the PDUFA action date is September 14th, 2010, " stated Paul Hamelin, R.