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Amgen Inc.

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A Multicenter, Randomised, Double-blind, Placebo-controlled Study of Darbepoetin Alfa for the Treatment of Anaemic Subjects With Low or Intermediate-1 Risk Myelodysplastic Syndrome (MDS)
Enrollment: 147
Study Start Date: December 2011
Estimated Study Completion Date: August 2017
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
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Source: clinical trials.gov. https://clinicaltrials.gov/ct2/show/NCT01362140?term=aranesp+myelodyspla...

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
Aranesp (darbepoentin alpha) MDSOncology HematologicMyelodysplastic Syndrome (MDS)Erythropoiesis-stimulating agent (ESA)Erythrocyte precursor cells (bone marrow)

Mechanism of action: Aranesp (darbepoentin alpha), a recombinant human protein, increases the hemoglobin concentration to the lowest level sufficient to avoid the need for red blood cell transfusion via a synthetic form of the hormone erythropoietin.

Phase of Development: III

Event Type: Data: Phase III trial results

Dates: 2016-02-01 - 2016-03-31

Results:

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Phase 3 Study Demonstrates AranespĀ® (Darbepoetin Alfa) Reduces Red Blood Cell Transfusions In Patients With Myelodysplastic Syndrome (MDS)
First Phase 3 Data From Placebo-Controlled Study With an Erythropoiesis-Stimulating Agent (ESA) in Anemic Patients With MDS
Study Met Primary Endpoint and Key Secondary Endpoint of Erythroid Response
THOUSAND OAKS, Calif., Feb. 15, 2016 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the randomized, double-blind, placebo-controlled Phase 3 AranespĀ® (darbepoetin alfa) ARCADE trial met its primary endpoint of reducing the incidence of red blood cell transfusions in anemic patients with low and intermediate-1 risk MDS at the end of the blinded 25-week study period. Aranesp also significantly improved erythroid response, a key measure of the formation of new red blood cells. Detailed results will be submitted to a future medical conference and for publication.

Safety data was consistent with the known safety profile of Aranesp, and the adverse events were generally balanced between treatment arms. The adverse events reported in the Aranesp arm at least five percent more frequently than in the placebo group were fatigue, pyrexia, headache and myalgia.

MDS is among the most common type of bone marrow failure syndromes in adults.1 The disease occurs when immature blood cells do not mature in the bone marrow. Patients with MDS have fewer healthy white blood cells, red blood cells and platelets, and are at risk of infection, anemia or bleeding.2 Current treatments for MDS include blood transfusions, chemotherapy and stem cell transplants.

"We are pleased to see positive results from this study, as anemia treatment options for myelodysplastic syndrome are limited and can place a significant burden on patients," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen.
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Source: press release, 2/15/16. http://wwwext.amgen.com/media/news-releases/2016/02/phase-3-study-demons...

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