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REPATHA (EVOLOCUMAB) FOUR-YEAR OPEN-LABEL FOLLOW-UP STUDY PUBLISHED IN JAMA CARDIOLOGY Long-Term Study Identified No New Safety Concerns

REPATHA (EVOLOCUMAB) FOUR-YEAR OPEN-LABEL FOLLOW-UP STUDY PUBLISHED IN JAMA CARDIOLOGY Long-Term Study Identified No New Safety Concerns

Amgen today announced that results from the Repatha (evolocumab) OSLER-1 study, were published inJAMA Cardiology. Repatha, when added to standard of care, achieved median low-density lipoprotein cholesterol reductions of 57 percent at four years, with no new safety concerns identified and no neutralizing antibodies observed with cumulative exposure.

Repatha (evolocumab) demonstrates REDUCED NEED FOR APHERESIS in PATIENTS with HIGH LDL CHOLESTEROL in Phase 3 study Study Meets Primary and All Secondary Endpoints

Amgen has announced positive top-line results from a Phase 3 study evaluating Repatha (evolocumab) in patients who were receiving apheresis to reduce low-density lipoprotein cholesterol (LDL-C). The study met its primary endpoint, demonstrating that treatment with Repatha significantly reduced the need for LDL-C apheresis in adult patients, as measured at the end of the randomized period.

LANDMARK OUTCOMES STUDY SHOWS THAT REPATHA (EVOLOCUMAB) DECREASES LDL-C TO UNPRECEDENTED LOW LEVELS AND REDUCES RISK OF CARDIOVASCULAR EVENTS WITH NO NEW SAFETY ISSUES

LANDMARK OUTCOMES STUDY SHOWS THAT REPATHA (EVOLOCUMAB) DECREASES LDL-C TO UNPRECEDENTED LOW LEVELS AND REDUCES RISK OF CARDIOVASCULAR EVENTS WITH NO NEW SAFETY ISSUES

Amgen has announced that the 27,564-patient Repatha (evolocumab) cardiovascular outcomes study, FOURIER, maximally reducing low-density lipoprotein cholesterol levels with Repatha, beyond what is possible with the current best therapy alone, leads to a further reduction in major cardiovascular events, including heart attacks, strokes and coronary revascularizations.

Nya fas III-data: Signifikant bättre överlevnad vid myelom med Kyprolis

Nya fas III-data: Signifikant bättre överlevnad vid myelom med Kyprolis

Världens första fas III-studie som jämför proteasomhämmare visar att Kyprolis förbättrar den totala överlevnaden signifikant jämfört med Velcade hos patienter med myelom. – Vi vet från tidigare studier att Kyprolis förlänger tiden till nästa återfall i sjukdomen, men nu ser vi också en substantiell skillnad i total överlevnad, säger Cecilie Hveding Blimark, Sahlgrenska Universitetssjukhuset.

REPATHA (EVOLOCUMAB) SIGNIFICANTLY REDUCED THE RISK OF CARDIOVASCULAR EVENTS IN FOURIER OUTCOME STUDY

Amgen has announced that the FOURIER trial evaluating whether Repatha (evolocumab) reduces the risk of cardiovascular events in patients with clinically evident atherosclerotic cardiovascular disease met its primary composite endpoint (cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, hospitalization for unstable angina or coronary revascularization).

STUDY RESULTS PUBLISHED IN THE JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION SHOW AMGEN’S PARSABIV™ (ETELCALCETIDE) SIGNIFICANTLY REDUCED SERUM PARATHYROID HORMONE IN ADULTS WITH SECONDARY HYPERPARATHYROIDISM ON HEMODIALYSIS

Amgen today announced the JAMA publication of findings from three Phase 3 studies of Parsabiv (etelcalcetide), an investigational intravenous calcimimetic agent. The studies evaluated Parsabiv in adults with secondary hyperparathyroidism (sHPT) on hemodialysis and showed that the drug produced statistically significant and clinically meaningful reductions in serum parathyroid hormone (PTH) levels.

Michael Grövdal är läkare och medicinsk rådgivare vid Amgen.

Tidiga fas III-resultat: Xgeva förebygger skelettkomplikationer vid myelom

De första resultaten från fas III-studien ’482 visar att Xgeva är lika effektivt som bisfosfonater när det gäller att fördröja skelettkomplikationer vid myelom. – Många myelompatienter lider av nedsatt njurfunktion och kan därför inte behandlas med bisfosfonater. För dessa patienter är de här resultaten mycket hoppingivande, säger Michael Grövdal, hematolog och medicinsk rådgivare vid Amgen.

ESMO 2016: Förlängd överlevnad med Vectibix vid spridd tjocktarmscancer – effekten särskilt tydlig hos patienter med tumör utgången från vänster sida av tjocktarmen

ESMO 2016: Förlängd överlevnad med Vectibix vid spridd tjocktarmscancer – effekten särskilt tydlig hos patienter med tumör utgången från vänster sida av tjocktarmen

​Tillägg av antikroppen Vectibix till cytostatika ger signifikant förbättrad total överlevnad vid spridd tjocktarmscancer hos patienter där tumören inte har muterad RAS-gen. Nya retrospektiva analyser som presenterats vid ESMO-kongressen som pågår i Köpenhamn visar att detta är extra tydligt för de patienter som har tumör som uppstått i vänster del av tjocktarmen.

Amgen announces top-line results from Phase 3 Kyprolis (Carfilzomib) CLARION STUDY in newly diagnosed multiple myeloma patients

​Amgen has announced top-line results of the Phase 3 CLARION trial, which evaluated an investigational regimen of carfilzomib, melphalan and prednisone (KMP) versus bortezomib, melphalan and prednisone (VMP) with newly diagnosed multiple myeloma who were ineligible for hematopoietic stem-cell transplant. The trial did not meet the primary endpoint of superiority in progression-free survival (PFS).

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Om Amgen

Amgen discovers, develops 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.se

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