March 9, 2007
Patient safety and the appropriate use of all of our products are top priorities for Amgen.
Reports from several experimental studies evaluating the class of drugs known as erythropoiesis-stimulating agents (ESAs), including Aranesp® (darbepoetin alfa), EPOGEN® (Epoetin alfa), Procrit® (Epoetin alfa), NeoRecormon® (Epoetin beta) and Eprex® (Epoetin alfa), have raised safety concerns regarding the off-label use of these products to correct anemia or raise hemoglobin concentrations.
In these studies, physicians treated patients differently than recommended in the approved prescribing information. Nevertheless, we think it appropriate to include information about these studies in the labels for our products. To that end, Amgen has worked closely with the FDA to ensure that the information contained in the updated FDA-approved labeling for ESAs reflects the current state of knowledge about the safety of these important products. To read Amgen’s press release announcing the label revisions, click here.
The FDA is planning to review the safety and efficacy of ESAs at an upcoming meeting of the FDA’s Oncologic Drugs Advisory Committee (ODAC) on May 10, 2007. Amgen is looking forward to participating in the scientific discussion at ODAC, and to providing data to support the safety of our ESA products when used according to the FDA-approved labels. In the meantime, a synopsis of the Aranesp 103 study results, which in part prompted our discussions with the FDA, has been posted on publicly available Web sites, including clinicaltrials.gov and clinicalstudyresults.org.
Amgen is committed to providing timely and appropriate communications to healthcare professionals whenever we become aware of significant new safety information that could affect clinical practice. In November 2006, for example, Amgen issued a “Dear Healthcare Provider” letter alerting physicians to FDA’s Public Health Advisory regarding the results of Johnson & Johnson’s CHOIR trial in chronic kidney disease patients not on dialysis, even though that study explored hemoglobin targets beyond those currently recommended in all ESA labels. Amgen proactively sent copies of the advisory to all nephrologists and our sales team hand-carried the advisory into physicians’ offices. In addition, Amgen voluntarily issued a “Dear Healthcare Provider” letter regarding the initial results of the Aranesp 103 study. Now, Amgen is informing healthcare professionals about the revisions to the U.S. prescribing information through a joint “Dear Healthcare Professional” letter with Ortho Biotech and will post the letter and updated prescribing information on Amgen’s Web site, www.amgen.com. Over the coming weeks, our field force will be calling on healthcare professionals to communicate this important new safety information. These efforts demonstrate our commitment to guiding the appropriate use of our important medicines.
Aranesp is indicated for the treatment of chemotherapy-induced anemia and anemia associated with chronic kidney disease (CKD), for patients on dialysis and patients not on dialysis. EPOGEN® (Epoetin alfa) is indicated for the treatment of anemia associated with CKD, for patients on dialysis. Amgen always recommends that physicians and other prescribers carefully follow FDA-approved prescribing instructions.
Aranesp® (darbepoetin alfa) and EPOGEN® (Epoetin alfa) have favorable risk/benefit profiles in approximately four million patients with chemotherapy-induced anemia or CKD when administered according to the FDA-approved dosing guidelines.
The Aranesp and EPOGEN prescribing information, including important safety information, may be accessed at www.Aranesp.com and www.EPOGEN.com, respectively.
