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

Amgen Inc. (NASDAQ:AMGN) 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).

The updated boxed warning states that ESAs shortened overall survival and/or time-to-tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid and cervical cancers, when dosed to target a hemoglobin of greater than or equal to 12 g/dL.

In the "Increased Mortality and/or Tumor Progression" warning section of the updated labeling, the interim results of the Preoperative Epirubicin Paclitaxel Aranesp (PREPARE) study in neo-adjuvant breast cancer were added as well as follow up data from the Gynecologic Oncology Group study in cervical cancer.

Amgen and Johnson & Johnson have submitted all available clinical data to the FDA including the data from these two study studies now reflected in the product labeling, as well as data from other informative controlled clinical studies with ESAs in the oncology setting. In general, these results have not changed the benefit-risk profile significantly of ESAs in this setting from previously available data discussed at the May 4, 2004, and May 10, 2007, Oncologic Drugs Advisory Committee (ODAC) meetings. Amgen will address the science and safety of ESAs in oncology, including these new data, at an upcoming ODAC meeting next week on Thursday, March 13, 2008.

Amgen is informing healthcare professionals about the revisions to the U.S. prescribing information through a joint "Dear Healthcare Professional" letter with Ortho Biotech and will post the letter along with the updated prescribing information on Amgen's Web site, www.amgen.com.

"Amgen is committed to ensuring physicians and patients have the latest information about ESAs in order to make appropriate treatment decisions," said Sean Harper, Amgen's Chief Medical Officer. "Last year, we communicated the new safety information in several ways, including disseminating DHCP letters, posting the new labeling on our Web site, focusing promotional activity from March until the May ODAC on warnings and safety data, and hosting ongoing briefings with the oncology community."

Amgen's ongoing risk management activities includes working with the FDA to design additional pharmacovigilance studies to address safety concerns around ESAs, developing a patient medication guide to communicate the benefit/risk of ESAs, and continuing to publicly communicate updates on ESAs to the public and oncology community.

About Amgen
Amgen discovers, develops, manufacturers and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe and effective medicines from lab, to manufacturing plant, to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and our vital medicines, visit www.amgen.com.

Most Popular Now

Sanofi builds focus on rare blood disorders and ca…

Some of the most serious unmet patient needs today are in the field of hematology. Rare blood disorders and blood-related cancers continue to be a major focus of research...

Novartis rises to second place in 2018 Access to M…

Novartis ranked second in the 2018 Access to Medicine Index (ATMi), up from 3rd place in 2016, in recognition of its long-standing efforts to improve worldwide access to ...

FDA approves first treatment for Lambert-Eaton mya…

The U.S. Food and Drug Administration today approved Firdapse (amifampridine) tablets for the treatment of Lambert-Eaton myasthenic syndrome (LEMS) in adults. LEMS is a r...

FDA approves new treatment for patients with acute…

The U.S. Food and Drug Administration today approved Daurismo (glasdegib) tablets to be used in combination with low-dose cytarabine (LDAC), a type of chemotherapy, for t...

FDA grants breakthrough device designation to arti…

Bayer announced today that the U.S. Food and Drug Administration (FDA) granted Breakthrough Device Designation to the Artificial Intelligence Software for Chronic Thrombo...

U.S. FDA approves Larotrectinib, the first TRK inh…

The U.S. Food and Drug Administration (FDA) has approved larotrectinib, the first oral TRK inhibitor, under the brand name Vitrakvi®. The approval is for the treatment of...

Pfizer reaches a global agreement with AbbVie

Pfizer Inc. (NYSE:PFE) has signed licensing agreements with AbbVie, resolving all global intellectual property matters for Pfizer's proposed adalimumab biosimilar. Under ...

Merck and Pfizer provide update on avelumab in pla…

Merck and Pfizer Inc. (NYSE: PFE) today announced that the Phase III JAVELIN Ovarian 200 trial evaluating avelumab* alone or in combination with pegylated liposomal doxor...

New study reveals probiotics do not help children …

Probiotics are a multibillion-dollar industry with marketing claims of being an effective treatment for a multitude of ailments, including diarrhea. However, findings fro...

Bristol-Myers Squibb awards "Golden Tickets…

Bristol-Myers Squibb Company (NYSE: BMY) and LabCentral, an innovative, shared laboratory space designed as a launchpad for life-sciences and biotech startups, today anno...

Alcon to highlight its vision, strategy and benefi…

Alcon, the eye care division of Novartis, will today hold its first Capital Markets Day for investors and analysts in relation to the previously-announced intention of No...

GSK reaches agreement to acquire TESARO, an oncolo…

GlaxoSmithKline plc (LSE/NYSE: GSK) and TESARO Inc (NASDAQ: TSRO) announced that the Companies have entered into a definitive agreement pursuant to which GSK will acquire...