Amgen (AMGN) Recalls Nine Packaged Lots Of Aranesp
8/13/2014 4:16:18 PM
Amgen Recalls Nine Packaged Lots Of Aranesp
August 14, 2014
By Mark Terry, BioSpace.com Breaking News Staff
California-based Amgen (AMGN) announced a voluntary recall in June, 2014 for nine lots of anemia medication Aranesp® (darbepoetin alfa). The lots were only in Europe and the Middle East and were recalled because several of the syringes were found to have cellulose and/or polyester particles in them.
Aranesp is used in the U.S. for the treatment of anemia associated with chronic renal failure, including for dialysis patients, non-dialysis patients, and in patients with non-myeloid malignancies where anemia is the result of chemotherapy. The affected lots contained 500 mcg prefilled syringes from non-U.S. distributors, wholesalers and several hospital pharmacies. The lot numbers are: 1042847, 1044141A, 1044141C, 1044141D, 1046891A, 1046891B, 1047394A, 1047622A, and 1047996A.
Amgen indicates the company believes the affected products have a very low potential to impact patients. Adverse reactions believed to be related to this can be reported to the FDA’s MedWatch Adverse Event Reporting program online, by mail or fax. To submit online: www.fda.gov/medwatch/report.htm; by mail or fax: www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request reporting form, and return to the address on the form, or fax to 1-800-FDA-0178.
Distribution in the U.S. was not affected by the recall. The countries involved were Belgium, Denmark, Finland, France, Ireland, Italy, Kuwait, Luxemburg, Russia, Saudi Arabia, Slovenia, Sweden, Switzerland and the U.K.
Amgen has also been in the news for the early completion of its FOCUS clinical trial for Kyprolis® (carfilzomib), which did not meet a primary endpoint of improved overall survival. However, the same drug has proved successful in the ASPIRE trial and is expected to be submitted worldwide for regulatory evaluation. The company is clearly facing several challenges including the end of some patent protection and plans to lay off 2,900 employees as the company restructures. On the other hand, net profits increased year-on-year by 26% to $1.8 billion. Despite the end of the patent exclusivity for many products, Amgen has a significant and promising clinical pipeline.
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