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HX575 epoetin alfa · 2 trials · 3 indications
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
Response to epoetin alfa in anemic patients with chronic renal failure is manifested by increased hematocrit, hemoglobin, reduced transfusion requirements and increase in quality of life. Hemoglobin (laboratory haematology parameter) is the primary endpoint of the study .
The incidence of antibody formation against epoetin in Radio-immuno-precipitation (RIP) assay
| Arm | Type | Description |
|---|---|---|
| HX575 epoetin alfa | EXPERIMENTAL | HX575, recombinant human epoetin alfa |
| US-licensed epoetin alfa | ACTIVE_COMPARATOR | US-licensed recombinant human epoetin alfa |
| HX575 epoetin alfa (Sandoz) | EXPERIMENTAL | Single arm |
| Name | Type | Description |
|---|---|---|
| HX575 epoetin alfa | DRUG | Solution for subcutaneous injection. The drug is administered subcutaneously at least once per week over 52 weeks. The dose will be individually titrated to maintain hemoglobin levels between 10 to 11 g/dL. |
| US-licensed epoetin alfa | DRUG | Solution for subcutaneous injection. |
| HX575 epoetin alfa (Sandoz) | DRUG | Eligible patients are scheduled to receive HX575 (INN: Epoetin alfa) as a solution for injection in order to achieve or maintain the correction of renal anemia. |
Inclusion Criteria: * Patients with end stage renal disease (stage CKD 5d), receiving stable subcutaneous maintenance therapy with Epogen® or Procrit® at least once per week * Mean hemoglobin level between 9.0 - 11.5 g/dL during the screening period * Adequate iron substitution Exclusion Criteria:...
HX575 epoetin alfa is an investigational biosimilar being developed for the treatment of anemia associated with chronic kidney disease (CKD). It is a small molecule therapeutic in the hematology area, studied in adult patients with CKD who have anemia.
HX575 epoetin alfa is being developed by Novartis AG, a company traded on the New York Stock Exchange under the ticker NVS. The drug is in Phase 3 clinical development for chronic kidney disease and anemia.
HX575 epoetin alfa is in Phase 3 clinical development. It is an investigational drug and has not been approved by regulatory authorities. Two Phase 3 trials have been completed, with one active-controlled study comparing it to US-licensed epoetin alfa.
HX575 epoetin alfa has been studied in two completed Phase 3 trials. NCT01576341 evaluated subcutaneous administration in chronic kidney disease patients across multiple countries, while NCT01693029 compared its safety and efficacy to US-licensed epoetin alfa in anemic CKD patients in the United States.
HX575 epoetin alfa is a proposed biosimilar to epoetin alfa, a reference biologic used to treat anemia. It was studied in a Phase 3 trial (NCT01693029) that directly compared HX575 to US-licensed epoetin alfa to establish similarity in safety and efficacy.