ARTICLE | Politics & Policy

CHMP advisory group to discuss ESAs

May 7, 2008 1:56 AM UTC

Amgen (NASDAQ:AMGN) said EMEA's CHMP asked the company and other marketers of erythropoiesis-stimulating agents (ESAs) to participate in a closed-door meeting of the Scientific Advisory Group on Oncology on May 15. According to Amgen, the companies have been asked to provide an overview of data that may help elucidate issues related to the impact of ESAs on tumor progression and survival in cancer patients. Last year, EMEA's CHMP proposed to amend the warning sections of the labels for ESAs, including AMGN's Aranesp darbepoetin alfa (See BioCentury Extra, Thursday, Sep. 27, 2007). ...