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    AMGN   US0311621009

AMGEN INC.

(AMGN)
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Amgen : Celebrates 20 Years of Aranesp« (darbepoetin alfa) as a Treatment for Patients With Chronic Kidney Disease

09/17/2021 | 06:02pm EDT

On September 17, 2001, the vision of one Amgen team was realized with the FDA approval of Aranesp® for treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis and not on dialysis.2

Steve Elliott, PhD, one of the key scientists involved in the development of Aranesp®, and a retired member of the Amgen team, shared how his team worked tirelessly to develop the treatment. However, behind those long hours was a team passionate about bringing a therapy to market that would make a difference in patients' lives.

The development of Aranesp® began shortly after the launch of EPOGEN® (epoetin alfa), Amgen's treatment for anemia due to CKD in patients on dialysis to decrease the need for red blood cell (RBC) transfusion. Following this launch, the EPOGEN® team continued to study anemia which led to the discovery, development, and eventually the launch of Aranesp®, a molecule with a longer half-life, which allows for reduced dosing frequency for CKD patients on dialysis and not on dialysis.2

'The team behind Aranesp® was motivated by an unmet patient need for a longer-acting preparation that would greatly impact patients' lives as it could be taken less often than earlier ESAs,' said Dr. Jeff Petersen, Clinical Research medical director in Nephrology at Amgen. ESAs (erythropoiesis-stimulating agents) are medications which stimulate the bone marrow to make red blood cells. 'It could help patients not on dialysis, along with pediatric patients which was a very big deal, and the fact that Amgen funded this research is a testament to the passion of the organization behind the product and the knowledge of its immense value for patients.'

Since its approval over 20 years ago, Amgen has continued to further develop Aranesp® while staying true to our original mission of impacting patients' lives.

'The original manufacturing process was developed with safety in mind and the risk-benefit profile of ESAs is well-characterized,' said Jim Gardner, global director, Operations at Amgen. 'Although this process has evolved over the past 20 years and has been adapted to patients' needs, we have still maintained the same product with regards to safety and efficacy and continue to serve more and more patients.'

'But perhaps what makes Aranesp® so special is the people behind it,' Gardner added. 'Like me, many other Amgen team members have been involved with Aranesp® since its launch and feel a real connection to this treatment and Amgen's roots. These teams are very motivated with a patients-first approach.'

Thanks to the hard work and dedication of thousands of Amgen employees, Aranesp® has been received by over seven million patients3,* across 62 countries, and has been studied in more than 19,000 patients during nephrology clinical trials.4 In fact, between April 2008 and December 2020, more than 290 million units of Amgen ESAs were distributed in the United States.5

Amgen is paving the way as a leader in the development of innovative treatments, with a passion to best serve patients, and the approval of EPOGEN® and Aranesp® are examples of this pioneering spirit in the field of anemia due to CKD.6

To learn more about Aranesp®, go to Aranesp.com

Indications
Aranesp® (darbepoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD), including patients on dialysis and patients not on dialysis.

EPOGEN® (epoetin alfa) is indicated for the treatment of anemia due to chronic kidney disease (CKD) in patients on dialysis to decrease the need for red blood cell (RBC) transfusion.

Limitations of Use:

  • Aranesp® and EPOGEN® have not been shown to improve quality of life, fatigue, or patient well-being.
  • Aranesp® and EPOGEN® are not indicated for use as a substitute for RBC transfusions in patients who require immediate correction of anemia.

Important Safety Information, including Boxed WARNINGS

WARNING: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE

Chronic Kidney Disease:

  • In controlled trials, patients experienced greater risks for death, serious adverse cardiovascular reactions, and stroke when administered erythropoiesis-stimulating agents (ESAs) to target a hemoglobin level of greater than 11 g/dL.
  • No trial has identified a hemoglobin target level, Aranesp dose, or dosing strategy that does not increase these risks.
  • Use the lowest Aranesp® or EPOGEN® dose sufficient to reduce the need for red blood cell (RBC) transfusions.

Cancer:

  • ESAs shortened overall survival and/or increased the risk of tumor progression or recurrence in clinical studies of patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers.
  • To decrease these risks, as well as the risk of serious cardiovascular and thromboembolic reactions, use the lowest dose needed to avoid RBC transfusions.
  • Use the lowest dose to avoid RBC transfusion.
  • Use ESAs only for anemia from myelosuppressive chemotherapy.
  • ESAs are not indicated for patients receiving myelosuppressive chemotherapy when the anticipated outcome is cure.
  • Discontinue following the completion of a chemotherapy course.

Perisurgery (EPOGEN®):

  • Due to increased risk of Deep Venous Thrombosis (DVT), DVT prophylaxis is recommended.
  • Aranesp®(darbepoetin alfa) and EPOGEN® (epoetin alfa) are contraindicated in patients with:
    • Uncontrolled hypertension
    • Pure red cell aplasia (PRCA) that begins after treatment with Aranesp®, EPOGEN®, or other erythropoietin protein drugs
    • Serious allergic reactions to Aranesp®or EPOGEN®
  • EPOGEN® from multidose vials contains benzyl alcohol and is contraindicated in neonates, infants, pregnant women, and lactating women.
  • Use caution in patients with coexistent cardiovascular disease and stroke.
  • Patients with CKD and an insufficient hemoglobin response to ESA therapy may be at even greater risk for cardiovascular reactions and mortality than other patients. A rate of hemoglobin rise of > 1 g/dL over 2 weeks may contribute to these risks.
  • In controlled clinical trials, ESAs increased the risk of death in patients undergoing coronary artery bypass graft surgery (CABG) and the risk of deep venous thrombosis (DVT) in patients undergoing orthopedic procedures.
  • Control hypertension prior to initiating and during treatment with Aranesp® or EPOGEN®.
  • Aranesp®and EPOGEN® increase the risk of seizures in patients with CKD. Monitor patients closely for new-onset seizures, premonitory symptoms, or change in seizure frequency.
  • For lack or loss of hemoglobin response to Aranesp®or EPOGEN®, initiate a search for causative factors. If typical causes of lack or loss of hemoglobin response are excluded, evaluate for PRCA.
  • Cases of PRCA and of severe anemia, with or without other cytopenias that arise following the development of neutralizing antibodies to erythropoietin have been reported in patients treated with Aranesp®or EPOGEN®.
    • This has been reported predominantly in patients with CKD receiving ESAs by subcutaneous administration.
    • PRCA has also been reported in patients receiving ESAs for anemia related to hepatitis C treatment (an indication for which Aranesp®and EPOGEN® are not approved).
    • If severe anemia and low reticulocyte count develop during treatment with Aranesp®or EPOGEN®, withhold Aranesp®or EPOGEN® and evaluate patients for neutralizing antibodies to erythropoietin.
    • Permanently discontinue Aranesp®or EPOGEN® in patients who develop PRCA following treatment with Aranesp®, EPOGEN®, or other erythropoietin protein drugs. Do not switch patients to other ESAs.
  • Serious allergic reactions, including anaphylactic reactions, angioedema, bronchospasm, skin rash, and urticaria may occur with Aranesp®or EPOGEN®. Immediately and permanently discontinue Aranesp®or EPOGEN® if a serious allergic reaction occurs.
  • Blistering and skin exfoliation reactions including Erythema multiforme and Stevens-Johnson Syndrome (SJS)/Toxic Epidermal Necrolysis (TEN), have been reported in patients treated with ESAs (including Aranesp® and EPOGEN®) in the postmarketing setting. Discontinue Aranesp® or EPOGEN® therapy immediately if a severe cutaneous reaction, such as SJS/TEN, is suspected.
  • Serious and fatal reactions including 'gasping syndrome' can occur in neonates and infants treated with benzyl alcohol-preserved drugs, including EPOGEN® multiple-dose vials. There is a potential for similar risks to fetuses and infants exposed to benzyl alcohol in utero or in breast-fed milk, respectively.
  • Adverse reactions (≥ 10%) in Aranesp®clinical studies in patients with CKD were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension.
  • Adverse reactions (≥ 5%) in EPOGEN® clinical studies in patients with CKD were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection.

Please see Aranesp®full Prescribing Information and EPOGEN®full Prescribing Information

*In the postmarketing setting from launch through December 31, 2020, the number of patients exposed is based on sales revenues data and includes both nephrology and oncology patients.

REFERENCES

  1. ARANESP® (darbepoetin alfa) FDA approval letter. September 17, 2001.
  2. Aranesp® (darbepoetin alfa) prescribing information, January 2019. Amgen.
  3. Data on file, Amgen; [ARANESP® Patient Years; 2021].
  4. Data on file, Amgen; [ARANESP® (darbepoetin alfa) Periodic Benefit-Risk Evaluation Report; Jan. 12, 2021].
  5. Data on file, Amgen; [ESA Units; 2021].
  6. Q2 RealTime Dynamix: Renal Anemia Report. 2021.

Disclaimer

Amgen Inc. published this content on 17 September 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 17 September 2021 22:01:00 UTC.


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