Nuts And Gout

Nuts And Gout 10 out of 10 based on 56 ratings.
 

S. Food and Drug Administration FDA-approved dose resulted in a statistically significant and sustained reduction in uric acid levels below 6 mg/dL in 42 percent of patients compared to zero percent of patients receiving placebo p 8.0 mg/dL. Nuts And Gout patients were randomly assigned to receive 12 two-week intravenous infusions containing either KRYSTEXXA 8 mg at each infusion every two-weeks or KRYSTEXXA alternating with placebo at successive infusions every four-week treatment group or placebo every two-week placebo group.

Words such as “anticipate” “believe” “estimate” “expect” “intend” “plan” “will” and other similar expressions identify forward-looking statements although not all forward-looking statements contain these identifying words. In particular any statements regarding the safety and efficacy of KRYSTEXXA status of our KRYSTEXXA marketing efforts and additional plans related thereto market demand and reimbursement for KRYSTEXXA our view of the refractory chronic gout RCG market size based on the completion of our recent comprehensive study and our market expansion plans including our MAA filing before the EMA are forward-looking

Nuts And Gout

statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information current expectations assumptions estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. We may not actually achieve the plans intentions or expectations disclosed in our forward-looking statements and you should not place undue reliance on our forward-looking statements which speak only as of the date of publication of this press release. Actual results or events could differ materially from the plans intentions and expectations disclosed in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions mergers dispositions joint ventures or investments that we may make. We do not have a policy of updating or revising forward-looking statements and except as required by law assume no obligation to update any forward-looking statements.

Patients who are at risk of having a condition known as G6 PD deficiency should be screened by their physician prior to starting therapy with KRYSTEXXA. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion. Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully. Most common adverse reactions:
Nuts And Gout
gout flares 77% infusion reactions 26% nausea 12% contusion or ecchymosis 11% nasopharyngitis 7% constipation 6% chest pain 6% anaphylaxis 5% and vomiting 5%. A significant sub-population of gout patients approximately 120000 are burdened with a difficult-to-treat form of the condition known as refractory chronic gout RCG. Symptoms of gout are caused by the body’s response to the presence of uric acid crystals in the joints and surrounding tissue which form when uric acid levels in the blood are elevated a condition called hyperuricemia.

Patients who are at risk of having a condition known as G6 PD deficiency should be screened by their physician prior to starting therapy with KRYSTEXXA. Exercise caution when using KRYSTEXXA in patients who have congestive heart failure and monitor patients closely following infusion. Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.

Although most cases of gout can be controlled with conventional urate-lowering therapy when uric acid levels remain high and symptoms persist despite treatment efforts chronic gout may be defined as refractory. Savient Pharmaceuticals Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA pegloticase for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University “Duke” and Mountain View Pharmaceuticals Inc. “MVP”. Duke developed the recombinant uricase enzyme and MVP developed the PEG ylation technology used in the manufacture of KRYSTEXXA. These risks trends and uncertainties are in some instances beyond our control.

S. Food and Drug Administration FDA-approved dose resulted in a statistically significant and sustained reduction in uric acid levels below 6 mg/dL in 42 percent of patients compared to zero percent of patients receiving placebo p 8.0 mg/dL. Patients were randomly assigned to receive 12 two-week intravenous infusions containing either KRYSTEXXA 8 mg at each infusion every two-weeks or KRYSTEXXA alternating with placebo at successive infusions every four-week treatment group or placebo every two-week placebo group.

Savient Pharmaceuticals Nuts And Gout Announces Publication of Pivotal Phase III KRYSTEXXA Data in JAMA Demonstrating Significant Benefits in Refractory Chronic Gout Patients The data demonstrated that treatment with KRYSTEXXA resulted in significant and sustained reductions in uric acid levels along with clinical improvements in a substantial proportion of RCG patients for six months a timeframe for demonstrating clinical improvement that is unique in randomized controlled studies of urate-lowering therapies. The two replicate randomized double-blind placebo-controlled Phase III studies were designed to evaluate the efficacy and tolerability of treatment with KRYSTEXXA 8 mg every two weeks or every four weeks

compared to placebo for the management of RCG patients. Pooled results from these studies demonstrated that treatment with KRYSTEXXA every two weeks the U. S. Food and Drug Administration FDA-approved dose resulted in a statistically significant and sustained reduction in uric acid levels below 6 mg/dL in 42 percent of patients compared to zero percent of patients receiving placebo p 8.0 mg/dL. Patients were randomly assigned to receive 12 two-week intravenous infusions containing either KRYSTEXXA 8 mg at each infusion every two-weeks or KRYSTEXXA alternating with placebo at

Nuts And Gout

successive infusions every four-week treatment group or placebo every two-week placebo group. Patients who are at risk of having a condition known as G6 PD deficiency should be screened by their physician prior to starting therapy with KRYSTEXXA.

Patients who are at risk of having a condition known as G6 PD deficiency should be screened by their physician prior to starting therapy with KRYSTEXXA. Exercise caution when using KRYSTEXXA in patients who have

congestive heart failure and monitor patients closely following infusion. Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully.

Patients receiving re-treatment may be at increased risk for anaphylaxis and infusion reactions and should be monitored carefully. Most common adverse reactions: gout flares 77% infusion reactions 26% nausea 12% contusion or ecchymosis 11% nasopharyngitis 7% constipation 6% chest pain 6% anaphylaxis 5% and vomiting 5%. A significant sub-population of gout patients approximately 120000 are burdened with a difficult-to-treat form of the condition known as refractory chronic gout RCG. Symptoms of gout are caused by the body’s response to the presence of uric acid crystals in the joints and surrounding tissue which form when uric acid levels in the blood are elevated a condition called hyperuricemia.

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