Amgen ESA Sales Dive In The Biotech’s “Toughest” Year
Sales of Amgen's Aranesp and Epogen took a hit in the fourth quarter as the safety of erythropoiesis-stimulating agents was questioned, Amgen reported during its fourth quarter and year-end earnings call Jan. 24. Going into 2008, the company will develop a risk management plan and other strategies to help address the situation
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The opening of a national coverage analysis comes with a public request for CMS to establish Medicare coverage limitations for ESA use in pre-dialysis and dialysis renal disease patient populations.
FDA and the sponsors of erythropoiesis-stimulating agents were mostly able to reach an agreement on safety revisions to labeling of the anemia therapies, but the agency was forced to employ its new regulatory authority to resolve a couple points of continued disagreement
Amgen could be facing a new threat on the reimbursement front just days after celebrating the removal of several "major overhangs" to its erythropoiesis-stimulating agents during its second quarter earnings call