http://www.amgennews.com/index.php en piroc@piroc.com Copyright 2008 2008-06-18T15:06:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_and_wyeth_statement_on_outcome_of_dermatologic_and_ophthalmic_drugs_a/ http://www.amgennews.com/index.php/2008NewsService/amgen_and_wyeth_statement_on_outcome_of_dermatologic_and_ophthalmic_drugs_a/#When:15:06:00Z  FDA Advisory Committee Recommends Enbrel(R) (etanercept) for the Treatment of Children and Adolescents with Chronic Moderate to Severe Plaque Psoriasis THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa. – June 18, 2008 – Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today issued the following statement on the outcome of today’s meeting of the U.S. Food and Drug Administration’s (FDA) Dermatologic and Ophthalmologic Drug Advisory Committee (DODAC) regarding the expanded use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis. Press Releases, Product News 2008-06-18T15:06:00+00:00 http://www.amgennews.com/index.php/2008NewsService/enbrel_application_for_the_treatment_of_pediatric_psoriasis_to_be_discussed/ http://www.amgennews.com/index.php/2008NewsService/enbrel_application_for_the_treatment_of_pediatric_psoriasis_to_be_discussed/#When:05:15:00Z  ENBREL Reviewed As Potential New Treatment Option for Children and Adolescents with Chronic Moderate to Severe Plaque Psoriasis Who Have Tried Another Therapy THOUSAND OAKS, Calif.--(BUSINESS WIRE)--June 18, 2008--Amgen (NASDAQ:AMGN) announced that the supplemental Biologics License Application (sBLA) for ENBREL for the treatment of pediatric patients with chronic moderate to severe plaque psoriasis who have tried another therapy will be discussed today at a meeting of the DODAC. Moderate to severe plaque psoriasis is a serious, chronic inflammatory disease that can have both physical and psychosocial impact. According to a study published in the British Journal of Dermatology, chronic psoriasis can have as much of an impact on a child’s physical, psychological and social functioning as other serious childhood diseases such as asthma, epilepsy and diabetes. Press Releases, Product News 2008-06-18T05:15:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_statement_on_briefing_materials_prepared_for_june_18_2008_dodac_meeti/ http://www.amgennews.com/index.php/2008NewsService/amgen_statement_on_briefing_materials_prepared_for_june_18_2008_dodac_meeti/#When:06:14:01Z Briefing documents for the June 18 Dermatologic and Ophthalmic Drugs Advisory (DODAC) meeting regarding the supplemental biologics license application (sBLA) for Enbrel® (etanercept) for the treatment of moderate to severe plaque psoriasis in the pediatric population are now available at www.fda.gov. Amgen believes that ENBREL would provide an important clinical option if approved for this small, under-served population of children with moderate to severe plaque psoriasis, and looks forward to discussing with the DODAC and FDA the benefits and risks of ENBREL treatment for these patients who have few approved therapies to help manage their disease. Product News 2008-06-16T06:14:01+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_to_participate_in_dodac_meeting_in_june/ http://www.amgennews.com/index.php/2008NewsService/amgen_to_participate_in_dodac_meeting_in_june/#When:06:15:00Z THOUSAND OAKS, Calif. – May 1, 2008 – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has asked the Company to participate in a meeting of the Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) on June 18, 2008. The DODAC will review data supporting the supplemental Biologic License Application (sBLA) submitted by Amgen for the use of ENBREL in treating pediatric patients with chronic moderate to severe plaque psoriasis, who are inadequately controlled with topical therapy or who have received systemic therapy or phototherapy. Press Releases, Product News 2008-05-01T06:15:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_and_wyeth_announce_updates_to_us_prescribing_information_for_enbrelr/ http://www.amgennews.com/index.php/2008NewsService/amgen_and_wyeth_announce_updates_to_us_prescribing_information_for_enbrelr/#When:12:47:00Z THOUSAND OAKS, Calif. & COLLEGEVILLE, Pa.—March 17, 2008—Amgen (NASDAQ: AMGN) and Wyeth Pharmaceuticals, a division of Wyeth (NYSE: WYE), today announced updates to the U.S. Food and Drug Administration (FDA)-approved U.S. Prescribing Information (PI) for Enbrel® (etanercept). Press Releases, Product News 2008-03-17T12:47:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_statement_on_outcome_of_esa_odac_meeting/ http://www.amgennews.com/index.php/2008NewsService/amgen_statement_on_outcome_of_esa_odac_meeting/#When:23:13:00Z THOUSAND OAKS, Calif., (March 13, 2008) – Amgen Inc. (NASDAQ: AMGN) today issued the following statement on the outcome of the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) meeting on the benefits and risks of erythropoiesis-stimulating agents (ESAs) in oncology. Product News 2008-03-13T23:13:00+00:00 http://www.amgennews.com/index.php/2008NewsService/this_is_an_internal_title_only_will_not_published_128_characters_max/ http://www.amgennews.com/index.php/2008NewsService/this_is_an_internal_title_only_will_not_published_128_characters_max/#When:05:15:00Z ESAs Provide Important Clinical Benefits to Cancer Patients With Anemia Due to Chemotherapy; Ongoing and Planned Risk Management Will Further Reduce Risks  THOUSAND OAKS, Calif.—March 13, 2008—Amgen Inc. (NASDAQ: AMGN) will today present the benefits and risks of Erythropoiesis-stimulating Agents (ESAs) in cancer patients with anemia due to concomitantly administered chemotherapy at a meeting with the U.S. Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC). ESAs provide these patients with the only therapeutic alternative to red blood cell (RBC) transfusions, which have known and uncertain risks. Press Releases, Product News 2008-03-13T05:15:00+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_statement_on_esas_odac_briefing/ http://www.amgennews.com/index.php/2008NewsService/amgen_statement_on_esas_odac_briefing/#When:13:12:01Z Briefing documents for the March 13th Oncologic Drugs Advisory (ODAC) meeting regarding erythropoiesis-stimulating agents (ESAs) are now available at www.fda.gov. Amgen strongly believes that ESAs provide an important clinical option for some patients, and looks forward to collaborating with the ODAC and FDA to maximize the benefits of these drugs when used according to the approved labeling while minimizing the risks. To view the Amgen statement, click here. Product News 2008-03-11T13:12:01+00:00 http://www.amgennews.com/index.php/2008NewsService/amgen_announces_update_to_uaranesp_and_epogen_pi/ http://www.amgennews.com/index.php/2008NewsService/amgen_announces_update_to_uaranesp_and_epogen_pi/#When:22:24:02Z THOUSAND OAKS, Calif., Mar 07, 2008 —Amgen Inc. (NASDAQ:AMGN) today announced the U.S. Food and Drug Administration (FDA) has approved updated safety information, including an updated boxed warning in the labeling information for the class of drugs known as erythropoiesis-stimulating agents (ESAs), including Aranesp(R) (darbepoetin alfa) and EPOGEN(R) (Epoetin alfa). Press Releases, Product News 2008-03-07T22:24:02+00:00 http://www.amgennews.com/index.php/2008NewsService/eu_commission_approves_updated_aranesp_pi/ http://www.amgennews.com/index.php/2008NewsService/eu_commission_approves_updated_aranesp_pi/#When:03:01:00Z THOUSAND OAKS, Calif.—March 5, 2008—Amgen (NASDAQ: AMGN) today announced that the European Commission reached its final decision to amend the prescribing information for Aranesp(R) (darbepoetin alfa) based on the positive opinion from the European Committee for Medicinal Products for Human Use (CHMP) in January 2008. The CHMP granted positive opinions for all centrally-authorized Erythropoiesis Stimulating Agents (ESAs) in the European Union (EU), each of which will receive European Commission Decisions. The European Commission’s decision announced today is consistent with that described in Amgen’s press release on Sept. 28, 2007 and the European Medicines Agency’s (EMEA) announcement on Oct. 23, 2007. Press Releases, Product News 2008-03-05T03:01:00+00:00