Drugs in the Pipeline Analysis

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Generic Drug Name (Brand) Drug Company Route Indication(s) Regulatory Priority review * Status Therapeutic Considerations Affected Population Estimated Peak Sales Estimated Cost/day Oral are suboptimally controlled with levodopa (L-dopa). In a phase III study, Requip XL 24-hour (n = 201) was titrated upwards from 2 mg/day to a maximum dose of 24 mg/day over the course of 24 weeks. At 8 mg/day, and with each subsequent dose increase, L-dopa dose reduction was required. Patients who did not experience improvements in symptoms after two up-titrations of ropinirole could have their L-dopa dose increased back up to baseline levels. At week 24, the reduction in mean awake "off" time was significantly greater in the ropinirole group compared with those in the placebo group. The adjusted mean change from baseline was -2.1 hours and -0.3 hours in the treated and placebo groups, respectively, leaving an adjusted mean treatment difference of - 1.7 hours (P
Generic Drug Name (Brand) Drug Company Route Indication(s) Regulatory Priority review * Status Therapeutic Considerations Affected Population Estimated Peak Sales Estimated Cost/day continuous erythropoiesis receptor activator (Mircera ) Roche Injection For the treatment of anemia in patients with chronic kidney disease, either on dialysis or not on dialysis NDA submitted: 4/2006 Approvable: 5/2007 Estimated approval date: 4Q 2007 Mircera (Continuous Erythropoietin Receptor Activator, CERA) is under FDA review for the treatment of anemia in chronic kidney disease (CKD) patients. Roche plans to differentiate Mircera based on a potential dosing advantage in chronic kidney disease. Mircera is administered every four weeks, while Epogen is dosed weekly and Aranesp is approved for weekly or every 3 week dosing. Amgen believes that Roche's method of manufacture infringes patents covering their anemia treatment Epogen. In November 2005, Amgen filed a patent infringement lawsuit against Roche seeking an injunction preventing the manufacture or sale of recombinant human erythropoietin, including pegylated versions. Amgen's patent infringement trial versus Roche has been set for September 2007. In December 2006, FDA extended its review of Mircera by three months after Roche submitted additional data for the compound. The extra data was submitted to "help give the FDA Anemia is a complication associated with CKD, from early stage illness to kidney failure requiring dialysis. Normally, when the body senses a decrease in oxygen, more erythropoietin is created by the kidneys which stimulates the production of oxygen-carrying red blood cells in the bone marrow. This raises the red blood cell count. When this natural mechanism is hindered (such as in kidney disease), it is necessary to stimulate the receptors in the bone marrow to $1 billion $40 - $50 per day Updated 8/2007 Copyright © 2007 Medco Health Solutions, Inc. 13
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Drugs in the Pipeline Analysis

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