Thursday, June 26, 2008

New Data Show Preemptive Treatment May Significantly Reduce Skin Toxicities in Patients Receiving Vectibix(R) (Panitumumab)

Study Adds to Body of Evidence on KRAS Mutational Status As a Predictive Biomarker of Vectibix Response

 BARCELONA, Spain – June 26, 2008 – Amgen (NASDAQ: AMGN) today announced updated results from the STEPP (Skin Toxicity Evaluation Protocol with Panitumumab) trial, the first prospective study to examine differences between preemptive and reactive skin treatment for skin toxicities in metastatic colorectal cancer (mCRC) patients receiving epidermal growth factor receptor (EGFr) therapy. The analysis found that preemptive treatment reduced the incidence rate of grade 2 and greater skin toxicities by over 50 percent without additional side effects when compared to reactive skin treatment. The incidence of grade 3 or greater skin toxicities were 62 percent and 29 percent in the reactive and preemptive treatment groups respectively (odds ratio (95 percent CI): 0.3 (0.1. 0.6)). These data were presented at the 10th World Congress on Gastrointestinal Cancer in Barcelona, Spain.

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Wednesday, June 18, 2008

Amgen and Wyeth Statement on Outcome of Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting

 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.

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Wednesday, June 18, 2008

Enbrel(R) (etanercept) Application for the Treatment of Pediatric Psoriasis to be Discussed at FDA Dermatologic and Ophthalmic Drugs Advisory Committee (DODAC) Meeting

 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.

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Monday, June 16, 2008

Amgen Statement on Briefing Materials Prepared for June 18, 2008 DODAC Meeting

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.

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Sunday, June 15, 2008

Romiplostim Data Show Potential Long-Term Efficacy and Safety in Adults with Chronic ITP

Results Show Romiplostim Increased and Sustained Platelet Counts with Extended Treatment

COPENHAGEN, Denmark – June 15, 2008 – Amgen Inc. (NASDAQ: AMGN) today announced updated results from the ongoing, open-label extension study on the long-term safety and efficacy of romiplostim in adult patients with chronic immune thrombocytopenic purpura (ITP), a chronic and serious autoimmune disorder characterized by low platelet counts in the blood. The updated results continue to show that romiplostim increased and sustained platelet counts with extended treatment, and reduced the need for concurrent and rescue ITP medications.

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