Throughout this section of the package insert, the Aranesp™ study numbers In 2 open-label studies, Aranesp™ or Epoetin alfa were administered for the. Package Insert Aranesp (Darbepoetin alfa) Amgen Inc. Table of Contents. Description Clinical Pharmacology Clinical Studies Indications and. This patient package insert contains information and directions for patients who will be receiving injections of Aranespä and their caregivers.
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Indication as per For the treatment of anaemia associated with chronic renal failure product monograph: CRFincluding patients on dialysis and patients not on dialysis. Date of First Sale: August In most cases, patents are issued before insegt drugs come to market. In this case, the first patent pertaining to Aranesp was issued November 5, and it came aranrsp the PMPRB’s jurisdiction at that time.
The introductory prices of Aranesp at date of first sale were found to be within the Guidelines because the cost of therapy did not exceed the cost of therapy of existing drugs in the therapeutic class comparison or did not do so by an amount sufficient to trigger the investigation criteria and the prices did not exceed the range of prices in other comparator countries where Aranesp was sold. For information on the Criteria for Commencing an Investigation, please see Schedule 5 of the Compendium of Guidelines Policies and Procedures, as posted on our website under Legislation, Regulations and Guidelines.
The Therapeutic Class Comparison TCC test of the Guidelines provides that the price of a category 3 new drug product cannot exceed the prices of other drugs that treat the same disease or condition. Comparators are generally selected from among existing drug products in the same 4th level of the Anatomical, Therapeutic, Chemical ATC System that are clinically equivalent in addressing the approved indication.
The only other agent that falls within the same 4th level ATC class as Aranesp is Eprex epoetin alfa. Eprex also shares the same indication as Aranesp and is used in Canada for treating anaemia in patients with chronic renal failure.
Aranesp® (darbepoetin alfa)
The PMPRB’s Guidelines provide that the dosage recommended for comparison apckage will normally not be higher than the maximum of the usual recommended dosage.
The recommended comparable dosage regimens for Aranesp and the comparator are based on the respective product monographs and supported by clinical literature.
See the following table. Under the Guidelines, the introductory packaeg of a new category 3 drug inaert will be presumed to be excessive if it aranes the prices of all of the comparable drug products based on the TCC test, and if it exceeds the prices of the same medicine in the seven countries listed in the Patented Medicines Regulations.
As shown in the table below, the prices of Aranesp were considered within the Guidelines relative to the TCC test as they did not exceed the prices of the other drugs in the therapeutic class or did not do so by an amount that triggered the investigation criteria. In compliance with the Guidelines, the prices in Canada did not exceed the range of prices in those countries; the prices in Canada were lower than the prices in those countries.
The publication of these reports is also part of the PMPRB’s commitment to make its price review process more transparent. The information contained in the PMPRB’s Summary Reports should not be relied upon for any purpose other than its stated purpose and is not to be interpreted as an endorsement, recommendation or approval of any drug nor is it intended to be relied upon as a substitute for seeking appropriate advice from a qualified health care practitioner. Product Monograph of Aranesp darbepoetin alfa.
Novel erythropoiesis stimulating protein NESP corrects anemia in dialysis patients when administered at reduced dose frequency compared with recombinant-human erythropoietin abstract. J Am Soc Nephrol ;11 suppl: Novel erythropoiesis stimulating protein for treatment of anaemia in chronic renal failure.
J Am Soc Nephrol ;10 suppl: Novel erythropoiesis stimulating protein NESP safely maintains hemoglobin concentration levels in hemodialysis patients as effectively as r-HuEPO when administered once weekly.
Novel erythropoiesis stimulating protein NESP effectively maintains hemoglobin when administered at a reduced dose frequency compared with recombinant human erythropoietin in dialysis patients. Practical guidelines for the use of NESP in treating renal anemia.
Report on New Patented Drugs – Aranesp
Nephrol Dial Transplant ;16 suppl 3: An overview of the efficacy and safety packagf novel erythropoiesis stimulating protein NESP. Novel erythropoiesis stimulating protein for managing the anaemia of chronic kidney disease. Am J Kidney Diseases ; August 2, Date of First Sale: