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Efficacy
Our phase 3 clinicals trials proved that 75.6% of the study subject of Efepoetin Alfa was able to achieve a > 1 g/dL Hb increase with mean Hb within 10-12 g/dL.

Efepoetin Alfa established a non-inferiority status towards methoxy polyethylene glycol-epoetin beta on several endpoints. In the Efepoetin Alfa Q2W group, the response rate was 75.6%; while in the methoxy polyethylene glycol-epoetin beta Q2W group, the response rate was 69.3%. The difference in the response rate was 6.3% with 95% CI (Confidence Interval) -3.1% to 15.5%. The lower limit of the 95% CI was above the prespecified non-inferiority margin of -9.0%.

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91.28% of the subject able to maintain Hb concentration within ±1 g/dL of the mean value during the study.

Study Design

Subject characteristics:

  • ESA naive

  • CKD stage 3-4

  • Not on dialysis

  • Serum ferritin >= 100 mcg/L

  • TSAT >=20%

  • Normal B12 / folic acid

55 Sites

Indonesia

Australia

Thailand

Taiwan

Malaysia

Philipines

South Korea

7 country

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Clinical Trial Results of

EFESA

for Non-Dialysis CKD

Mean Hemoglobin During Correction, Evaluation Period, and Extention Period
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Safety
Treatment-related Treatment Emergent Adverse Events (TR-TEAE) during Corrective treatment and Evaluation Period with Efepoetin Alfa every two weeks (Q2W)
Safety
Treatment-related Treatment Emergent Adverse Events (TR-TEAE) during Extension Period with Efepoetin alfa every two weeks (Q2W) and every four weeks (Q4W)

  • Evaluations of laboratory parameters did not show any specific safety trends, and no apparent trends observed across the treatment groups in the percentage of subject having values outside the normal range in clinically significant values.

  • During our clinical trials, anti-efepoetin alfa antibodies were not detected in any subject

  • A. Warnings

    1. A dose capable of maintaining the least blood Hb level not requiring RBC transfusion shall be administered.

    2. After the drug administration, if the blood Hb level exceeds 12 g/dL, risks of SAEs of the cardiovascular system and death will increase.

    3. The frequency of deep vein thrombosis was high in patients who used EPOs preoperatively to reduce the transfusion of homologous RBCs.

    4. Antibody-mediated PRCA has been rarely reported after months to years of subcutaneous epoetin treatment in Chronic Renal Failure patients. If anti-erythropoietin, antibody-mediated PRCA is suspected, therapy with EFESA should be discontinued immediately. No other ESA therapy should be commenced because of the risk of cross-reaction. Appropriate therapy, such as blood transfusions, may be given to patients when indicated.

    5. In all patients, hemoglobin concentrations should be closely monitored due to a potential increased risk of thromboembolic events and fatal outcomes when patients are treated at hemoglobin concentrations above the range for the indication of use.

     

    B. Precautions

    This product must be carefully administered to any patients with:

    1. Renal anemia who are receiving EPOs.

    2. Hypertension (increased blood pressure has been reported after administering Efepoetin alfa, therefore, hypertensive patients must follow antihypertensive treatment and dietary control during treatment with this drug).

    3. History of drug hypersensitivity.

    4. Predisposition to allergy.

    5. Myocardial infarction, pulmonary infarction, and cerebral infarction (since thromboembolism resulting from administration of this drug was reported, this drug has a risk of aggravating or causing thromboembolism).

    6. Liver disease (Efepoetin alfa is eliminated through the liver, so patients with active liver disease shall be excluded).

    7. The safety and efficacy of EFESA have not been established in patients with the underlying hematologic disease (e.g hemolytic anemia, sickle cell anemia, thalassemia).

    8. Epilepsy.

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    C. Special cautions for drug administration:

    1. Avoid co-administering this drug with any other drug.

    2. Visually inspect to confirm absence of foreign matter or discoloration, if any, before administration, and do not use any vials where foreign matter is found or if the contents are discolored.

    3. Do not use any drugs with insoluble matter seen, or if the solution is turbid.

    4. Never use any drugs that have been opened previously or whose primary package has been damaged.

    5. Do not attempt to use any fluids that have been frozen.

    6. To avoid injection site pains, gently inject this drug at different sites at every administration.

     

    D. INTERACTIONS

    Any interactions of other medications with this product have not been studied.

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