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Hyperuricemia in Medical News

FDA approves ULORIC (febuxostat) for the chronic management of hyperuricemia in patients with gout

Deerfield, Ill., and Osaka, Japan, February 13, 2009 Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced today that the United States Food and Drug Administration (FDA) has approved ULORIC (febuxostat) 40 mg and 80 mg for th...

The Gout & Uric Acid Education Society (GUAES) Announces New Survey Results Highlighting Major Gaps in Public Awareness of Gout

...ation, people with gout should not interpret a lack of symptoms as a "cure." Even when painful symptoms are not present, untreated gout and prolonged hyperuricemia can lead to permanent joint damage and deformity. Most experts agree that lowering a person's uric acid level to less than 6.0 mg/dL is helpful to pr...

Review of Takeda's Febuxostat New Drug Application Continues Past PDUFA Date

... look forward to receiving a final approval date for febuxostat." Febuxostat is currently under review with FDA for once-daily, oral treatment of hyperuricemia in patients with gout. The NDA for febuxostat included data from multiple clinical trials involving more than 4,000 patients. In November 2008, FDA'...

Pegloticase BLA Filing Accepted for Priority Review by FDA

... ABOUT PEGLOTICASE Pegloticase (formerly referred to as Puricase(R)) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials ass...

Basketball Star Details His Struggle With Gout

... Americans, and to debunk stereotypes about the so-called "disease of kings." According to GUAES, gouty arthritis results from a condition known as hyperuricemia -- the build-up of abnormally high levels of uric acid in the blood. A normal waste product that forms from the breakdown of purines found in cells an...

NBA Coach Maurice Cheeks Teams Up with the Gout & Uric Acid Education Society (GUAES) to Call a 'Time Out for Gout'

...Medical Center in Philadelphia, Pennsylvania. "Untreated gout and prolonged hyperuricemia can lead to an accumulation of needle-like urate crystals that not only cau... to reduce urate crystal accumulation and prevent the consequences of hyperuricemia and gout. It is important to work with your physician to monitor your...

AUA 2008: Uric acid stones may indicate arteriosclerotic diseases

... and urinary stone disease and concluded that arteriosclerotic diseases and hyperuricemia can be predictors of uric acid stones. 77.5 percent of all patients in ...type 2 diabetes, but the proportion of uric acid stones in elderly men with hyperuricemia and arteriosclerotic disease was significantly higher. Metabolic syndro...

Risk Of Heart Attack Increased By Gout

...d up of uric acid in blood. When chronic or severe hyperuricemia leads to urate crystals within joints, it results ...d Blood Institute. There were 5,337 men with hyperuricemia at the beginning of the study. Over the study peri...omotes atherogenesis and thrombogenesis is needed. hyperuricemia is well known to be an independent risk factor for...
Hyperuricemia in Medical Technology

Arthritis Advisory Committee Recommends FDA Approval of Febuxostat for the Treatment of Hyperuricemia in Patients With Gout

DEERFIELD, Ill., and OSAKA, Japan, Nov. 24 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Global Research & Development Center, Inc., U.S., announced today that the Arthritis Advisory Committee of the U.S. Food and Drug Administration (FDA) recomm...

New Data Shows Blood Pressure Reduction Therapy with BENICAR(R) and BENICAR HCT(R) Effectively Reduces Blood Pressure in Elderly Patients to Target Blood Pressure

...as dizziness (3% vs 1%) -- AEs reported in >2% of patients taking BENICAR HCT(R) and more frequently than placebo included nausea (3% vs 0%), hyperuricemia (4% vs 2%), dizziness (9% vs 2%), and upper respiratory tract infection (7% vs 0%) Dosing and Administration No initial dosage ...

New Report by BioTrends Research Group to Highlight the Launch of ULORIC(R) (febuxostat)

...hey received FDA approval for Uloric (R) (generic name: febuxostat) on February 13, 2009. Uloric (R) is indicated for the chronic management of hyperuricemia associated with gout and represents the first product for gout that has been approved in over forty years. LaunchTrends(TM): Uloric (R) is...

Savient Provides Update on Pegloticase BLA

...oticase) KRYSTEXXA (pegloticase) (formerly referred to as Puricase(R)) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials ass...

Phase III Trial Results Show Elitek(R) (rasburicase) Significantly Reduced Plasma Uric Acid Levels versus Allopurinol in Adults with Hematologic Cancers at Risk for Tumor Lysis Syndrome

...combination (p=0.0012). The PUA response rate among patients with baseline hyperuricemia defined as plasma uric acid >7.5mg/dL was 90% with Elitek versus 53% wit... at either high or potential risk for TLS: High risk for TLS was defined as hyperuricemia from the cancer at baseline (plasma uric acid >7.5 mg/dL), very aggressi...

New Study Shows BENICAR(R) (olmesartan medoxomil) Reverses Blood Vessel Damage Independent of Blood Pressure Lowering

...cebo was dizziness (3% vs 1%) -- AEs reported in > 2% of patients taking BENICAR HCT and more frequently than placebo included nausea (3% vs 0%), hyperuricemia (4% vs 2%), dizziness (9% vs 2%), and upper respiratory tract infection (7% vs 0%) Dosing and Administration -- No initial dosage adjustments ...

Ardea Biosciences Identifies Lead Development Candidate for Gout, RDEA594

...iple Doses of RDEA806, A Novel Prodrug for the Potential Treatment of hyperuricemia Location: Le Palais de Congres de Paris - Level 1 (Abstract # THU0356) ...rapies. No new therapies have been approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years. About RDEA594 RDEA594 is a d...

New Data Shows 45 Percent of Patients with Stage 1 Hypertension Reached Normotension with BENICAR(R) and BENICAR HCT(R)

...t vs 1 percent). AEs reported in > 2 percent of patients taking BENICAR HCT and more frequently than placebo included nausea (3 percent vs 0 percent), hyperuricemia (4 percent vs 2 percent), dizziness (9 percent vs 2 percent), and upper respiratory tract infection (7 percent vs 0 percent). No initial dosage adju...

Ardea Biosciences, Inc. Announces New Clinical Development Program Directed Toward the Treatment of Gout

...ging clinical efficacy study in gout patients with hyperuricemia in the first half of 2008. The Company is currentl...therapies approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years, and the...while 8% experienced serious adverse events (1). hyperuricemia in HIV There is a high prevalence of...

Benicar HCT Reductions in Seated Systolic Blood Pressure for Stage 2 Patients Compared With Amlodipine + Benazepril

...nt vs 1 percent). AEs reported in >2 percent of patients taking BENICAR HCT and more frequently than placebo included nausea (3 percent vs 0 percent), hyperuricemia (4 percent vs 2 percent), dizziness (9 percent vs 2 percent), and upper respiratory tract infection (7 percent vs 0 percent). No initial dosage adju...
Hyperuricemia in Medical Definition

Pathology

... 2 O Dehydration / Hypervolemia - K + Hypokalemia / Hyperkalemia - Cl − Hyperchloremia / Hypochloremia Purine and pyrimidine hyperuricemia - Lesch-Nyhan syndrome - Xanthinuria Porphyrin Acute intermittent , Gunther's , Cutanea tarda , Erythropoietic , Hepatoerythropoie...
Hyperuricemia in Medical Dictionary

Hyperuricemia

Hyperuricemia is a level of uric acid in the blood that is abnormally high. In humans, the upper end of the normal range is 360 µmol dL) for women and 400 µmol dL) for men. Features information on causes, symptoms, diagnosis, risk factors, and treatment of gouty arthritis. Watch thi...

Uric acid

...acid can cause attacks of gout and kidney stones. ... Gout - Gout and hyperuricemia are caused by uric acid crystals building up in the body. ... Gout and hyperuricemia are caused by uric acid crystals building up in the body. ... informat...
Hyperuricemia in Biological Technology

FDA Approves ULORIC(R) (febuxostat) for the Chronic Management of Hyperuricemia in Patients with Gout

First new treatment option in more than 40 years, marking second FDA approval for Takeda within one month DEERFIELD, Ill., and OSAKA, Japan, Feb. 13 /PRNewswire/ -- Takeda Pharmaceutical Company Limited and its wholly-owned subsidiary, Takeda Pharmaceuticals North America, Inc., announced tod...

FDA Appointed Arthritis Advisory Committee Recommends U.S. Food and Drug Administration Approval for KRYSTEXXA(TM) for Refractory Chronic Gout

...ty markets. Savient is currently developing one product: KRYSTEXXA(TM) (pegloticase) as a therapy for patients with treatment failure gout, to control hyperuricemia and to manage the signs and symptoms of gout. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA, formerly refer...

Savient Announces New Date for FDA Arthritis Advisory Panel Review of KRYSTEXXA(TM) for Treatment Failure Gout

...ugust 1, 2009. ABOUT KRYSTEXXA(TM) KRYSTEXXA (TM) (pegloticase) is a pegylated recombinant mammalian urate oxidase in development to control hyperuricemia and its clinical consequences in patients for whom conventional therapy is contraindicated or has been ineffective. The two Phase 3 pivotal trials ass...

Ardea Biosciences' Advances RDEA806 Into Phase 2a Proof-of-Concept Study for Gout

...ng normal sUA concentrations in gout patients with hyperuricemia (greater than or equal to 8.0 mg/dl). The primary ...cs related to rheumatology, and most frequently to hyperuricemia and gout. About Gout An estimated 3-5 million ...have been approved by the FDA for the treatment of hyperuricemia associated with gout in the past 40 years. About...
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