Approval Probability
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Also known as Epoetin alfa or beta
Epoetin · 4 trials · 1 indication
A time adjusted mean change in hemoglobin (Hb) concentration was calculated using an area under the curve (AUC) approach, for both periods separately. Change in Hb concentration between the baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb value from the average evaluation period Hb value. All blood samples for Hb measurements were taken prior to study drug administration. Analysis used last observation carried forward (LOCF) for missing Hb values to correct for the impact of early dropouts. The baseline period is defined as Week -4 to Week -1. The evaluation period is defined as Week 29 to Week 36.
A time adjusted mean change in Hb concentration was calculated using an Area Under the Curve (AUC) approach, for both periods separately. Change in Hb concentration between the Baseline and evaluation periods was calculated by subtracting the calculated average baseline Hb from the average evaluation period Hb. At the end of the Week 36, data allowing the evaluation of the therapeutic response was available for 188 out of 221 eligible participants in RO0503821 (1x/2 Weeks) arm; 172 out of 220 eligible participants in RO0503821 (1x/4 Weeks); and 180 out of 225 participants in Epoetin (1-3x/Weeks) arm.
| Arm | Type | Description |
|---|---|---|
| 1 | EXPERIMENTAL | - |
| 2 | ACTIVE_COMPARATOR | - |
| RO0503821 (1x/2 Weeks) | EXPERIMENTAL | Eligible participants received RO0503821 (Mircera \[methoxy polyethylene glycol-epoetin beta\]) subcutaneously, once every two weeks for 52 weeks. Participants received a starting dose of RO0503821 60, 100, or 180 microgram (mcg) which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 international units (IU)/week, administered during the week preceding the switch to the study drug. |
| RO0503821 (1x/4 Weeks) | EXPERIMENTAL | Eligible participants received RO0503821 subcutaneously, once every four weeks for 52 weeks. Participants received a starting dose of RO0503821 120, 200, or 360 mcg which was based on the epoetin dose of\<8000, 8000-16000, or \>16000 IU/week administered during the week preceding the switch to the study drug. |
| Epoetin Reference | ACTIVE_COMPARATOR | Eligible participants received their ongoing weekly subcutaneous dose of epoetin alfa or beta one, two or three times weekly for 52 weeks . |
| Epoetin (1-3x/Weeks) | ACTIVE_COMPARATOR | Participants received their ongoing weekly intravenous dose of Epoetin alfa or beta one, two or three times weekly for 52 weeks. |
| Name | Type | Description |
|---|---|---|
| epoetin alfa or beta | DRUG | iv or sc, as prescribed |
| methoxy polyethylene glycol-epoetin beta [Mircera] | DRUG | 30, 50 or 90 micrograms iv or sc (starting dose) every 2 weeks |
| methoxy polyethylene glycol-epoetin beta (Mircera) | DRUG | 60, 100 or 180 micrograms sc (starting dose) every 2 weeks |
| epoetin | DRUG | 3 times a week iv, as prescribed. |
| RO0503821 (1x/2 Weeks) | DRUG | 60, 100, or 180 microgram (mcg) (starting dose) once every two weeks intravenously for 52 weeks. |
| RO0503821 (1x/4 Weeks) | DRUG | 120, 200 or 360 mcg (starting dose) once every four weeks intravenously for 52 weeks. |
Inclusion Criteria: * adult patients \>=18 years of age; * chronic renal anemia; * on dialysis therapy for at least 12 weeks before screening; * receiving iv or sc epoetin for at least 8 weeks before screening. Exclusion Criteria: * women who are pregnant, breastfeeding or using unreliable birth ...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | Luspatercept |
| Takeda Pharmaceutical Co. Ltd. Sponsored ADR | TAK | 2 | PHASE3 | Elritercept |
| Disc Medicine, Inc. | IRON | 2 | PHASE2 | DISC-0974 |
| Akebia Therapeutics, Inc. | AKBA | 2 | PHASE3 | Vadadustat |
| Sunshine Biopharma Incorporated | SBFM | 1 | PHASE2 | HEC53856, rHuEPO |
| Ascentage Pharma Group International Unsponsored ADR | AAPG | 1 | PHASE1 | APG-5918 |
| Bayer | BAYRY | 1 | - | Molidustat |
Epoetin is used for the treatment of anemia. It is being developed by Roche Holding AG for anemia in dialysis patients, a hematology indication. A Phase 3 study of the drug enrolled 182 participants with anemia across the United States, Brazil, Canada, Czechia, Greece, Norway, Poland, Russia, South Africa, Spain, Sweden, Switzerland, and Thailand.
Epoetin targets EPOR, the erythropoietin receptor, and acts as an agonist at that receptor. By binding and activating EPOR, the drug stimulates erythropoiesis, the production of red blood cells, which is the basis for its use in anemia. EPOR agonism is the mechanism described for this small molecule.
Epoetin is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is the sponsor behind the clinical development program for the drug in anemia, including the Phase 3 study conducted in dialysis patients. The asset is listed in ChEMBL under the identifier CHEMBL1201565.
Epoetin is in Phase 3 clinical development for anemia. It is an investigational agent and is not described as approved. The Phase 3 program includes one completed trial with 182 enrolled participants; no trials for Epoetin are currently listed as active, so the completed study represents the reported clinical experience for this asset.
Epoetin has been studied in the Phase 3 trial NCT00077597, titled A Study of Mircera for the Treatment of Anemia in Dialysis Patients. That trial is completed, enrolled 182 participants aged 18 years and older of all sexes, and used an active-controlled design without blinding. It was conducted across multiple countries including the United States, Brazil, Canada, and several European and Asian sites.
Yes, Epoetin is also known as Mircera. The Phase 3 study NCT00077597 is titled A Study of Mircera for the Treatment of Anemia in Dialysis Patients, which links the Mircera name to this Epoetin asset developed by Roche Holding AG for anemia. Readers searching for Mircera are looking at the same drug.