Amgen News Service

Wednesday, March 12, 2008

Amgen Statement on Successful Outcome of Romiplostim Panel Meeting

THOUSAND OAKS, Calif.—March 12, 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 romiplostim, a investigational thrombopoietin mimetic peptibody, for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP).

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Posted in Press Releases, Pipeline News

Wednesday, March 12, 2008

Amgen to Discuss Romiplostim Application at FDA ODAC Meeting

Orphan Drug Romiplostim Reviewed as Potential New Treatment Approach for Serious Bleeding Disorder

THOUSAND OAKS, Calif.—March 12, 2008—Amgen Inc. (NASDAQ: AMGN) will discuss the proposed Biologic License Application (BLA) for romiplostim, an investigational thrombopoietin mimetic peptibody, for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP) today at the Oncologic Drugs Advisory Committee (ODAC). Patients with chronic ITP, a serious autoimmune disorder characterized by low platelet counts in the blood (thrombocytopenia) face the risk of bleeding events. Treatment of thrombocytopenia in adult patients with chronic ITP is considered an unmet medical need by the U.S. Food and Drug Administration (FDA) and has received orphan drug designation.

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Posted in Press Releases, Pipeline News

Tuesday, March 11, 2008

Amgen Statement on Briefing Materials Prepared for March 13, 2008 ODAC Meeting

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.

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Posted in Product News

Monday, March 10, 2008

Amgen Statement on Briefing Materials Prepared for March 12, 2008 ODAC Meeting

Briefing documents for the March 12th Oncologic Drugs Advisory Committee (ODAC) meeting regarding romiplostim are now available at www.fda.gov.

Amgen looks forward to a robust discussion with the Oncologic Drugs Advisory Committee (ODAC) on the proposed Biologic License Application (BLA) for romiplostim, an investigational thrombopoietin mimetic peptibody for the treatment of thrombocytopenia in adult patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), an orphan disease.

ITP is a serious autoimmune disorder that increases the risk of serious bleed events due to significant drops in platelet counts. Treatment of thrombocytopenia in adult patients with chronic ITP is considered an unmet need.

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Posted in Pipeline News

Friday, March 07, 2008

Amgen Announces Update to U.S. Prescribing Information for Aranesp(R) and EPOGEN(R)

Revised Boxed Warning Applies to Oncology Indication for the Class of Approved ESAs

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).

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Posted in Press Releases, Product News

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