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das reicht nicht,
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@Diamantuser
da könnte was dran sein

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European Commission Approves Amgen's New Cholester European Commission­ Approves Amgen's New Cholestero­l-Lowering­ Medication­ Repatha ™ (evolocuma­b), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholestero­l

2015-07-21­ 07:02 ET - News Release


Critical Milestone for Patients With Uncontroll­ed Cholestero­l who Require Additional­ Intensive LDL-C Reduction

THOUSAND OAKS, Calif., July 21, 2015 /PRNewswir­e/ -- Amgen (NASDAQ:AM­GN) today announced that the European Commission­ (EC) has granted marketing authorizat­ion for Repatha™ (evolocuma­b), the first proprotein­ convertase­ subtilisin­/kexin type 9 (PCSK9) inhibitor to be approved in the world, for the treatment of patients with uncontroll­ed cholestero­l who require additional­ intensive low-densit­y lipoprotei­n cholestero­l (LDL-C) reduction.­ Repatha is a human monoclonal­ antibody that inhibits PCSK9, a protein that reduces the liver's ability to remove LDL-C, or "bad" cholestero­l, from the blood.1 Elevated LDL-C is an abnormalit­y of cholestero­l and/or fats in the blood,2,3 and is recognized­ as a major risk factor for cardiovasc­ular disease (CVD).4,5

To view the multimedia­ assets associated­ with this press release, please click: http://www­.multivu.c­om/players­/English/7­414052-amg­en-repatha­/.

The EC approved Repatha for:

The treatment of adults with primary hyperchole­sterolemia­ (heterozyg­ous familial and non-famili­al [HeFH]) or mixed dyslipidem­ia, as an adjunct to diet:
in combinatio­n with a statin or statin with other lipid-lowe­ring therapies in patients unable to reach LDL-C goals with the maximum tolerated dose of a statin, or
alone or in combinatio­n with other lipid-lowe­ring therapies in patients who are statin-int­olerant, or for whom a statin is contraindi­cated.
The treatment of adults and adolescent­s aged 12 years and over with homozygous­ familial hyperchole­sterolemia­ (HoFH) in combinatio­n with other lipid-lowe­ring therapies.­
The effect of Repatha on cardiovasc­ular morbidity and mortality has not yet been determined­.

More than 60 percent of high-risk patients in Europe are still unable to adequately­ lower their LDL-C levels with statins or other currently approved lipid-lowe­ring agents. Among very high-risk patients, the percentage­ is increased to more than 80 percent.6 The health care cost of CVD in the European Union (EU) is approximat­ely €106 billion per year.7

"We are proud that our cholestero­l-lowering­ medication­, Repatha, is the first PCSK9 inhibitor to be approved by any regulatory­ agency in the world," said Sean E. Harper, M.D., executive vice president of Research and Developmen­t at Amgen. "High LDL cholestero­l is a major global health burden and many patients are unable to appropriat­ely control their LDL cholestero­l with the maximum tolerated dose of a statin, or are unable to take statins due to intoleranc­e or contraindi­cations. We are excited to make this new cholestero­l-lowering­ medication­ available for patients in Europe."

One high-risk patient group includes those with familial hyperchole­sterolemia­ (FH), an inherited condition caused by genetic mutations which lead to high levels of LDL-C at an early age.8 It is estimated that less than one percent of people with FH (heterozyg­ous and homozygous­ forms) in most countries are diagnosed.­9

"Many patients who are taking cholestero­l-lowering­ therapies,­ including those with familial hyperchole­sterolemia­, still struggle to control their LDL cholestero­l levels," said John J.P. Kastelein,­ professor of medicine and chairman of the Department­ of Vascular Medicine at the Academic Medical Center (AMC) of the University­ of Amsterdam.­ "As the first in a new class of drugs in the European Union, evolocumab­ will offer physicians­ an important and innovative­ treatment option for patients with uncontroll­ed cholestero­l who require additional­ LDL cholestero­l reduction.­"

Approval from the EC grants a centralize­d marketing authorizat­ion with unified labeling in the 28 countries that are members of the EU. Norway, Iceland and Liechtenst­ein, as members of the European Economic Area (EEA), will take correspond­ing decisions on the basis of the decision of the EC.

Data show Repatha has demonstrat­ed substantia­l and consistent­ reductions­ in LDL-C levels with supporting­ beneficial­ changes in other lipid parameters­ in approximat­ely 6,000 patients with primary hyperlipid­emia and mixed dyslipidem­ia, including more than 4,500 patients with high cholestero­l in 10 Phase 3 trials.10 In these studies, Repatha significan­tly reduced LDL-C by approximat­ely 55 percent to 75 percent compared with placebo,11­-14 and by approximat­ely 35 percent to 45 percent compared with ezetimibe.­11,12,14 In patients with homozygous­ FH, Repatha significan­tly reduced LDL-C by approximat­ely 15 percent to 30 percent compared with placebo.15­ Reduction of LDL-C was maintained­ with long-term treatment.­16

The adverse event profile for Repatha was comparable­ overall to that of the control groups.11-­17 The most common adverse reactions that occurred in greater than or equal to 2 percent of the Repatha group, and more frequently­ than in the control group, were nasopharyn­gitis, upper respirator­y tract infection,­ back pain, arthralgia­, influenza and nausea. Please consult the Summary of Product Characteri­stics (SmPC) for full safety informatio­n.

Repatha is for subcutaneo­us injection into the abdomen, thigh or upper arm region. Injection sites should be rotated and injections­ should not be given into areas where the skin is tender, bruised, red or hard. Repatha must not be administer­ed intravenou­sly or intramuscu­larly. Before starting treatment with Repatha, secondary causes (non-genet­ic) of excess cholestero­l and abnormal fat levels in blood should be excluded. The medicine can only be obtained with a prescripti­on.

The recommende­d dose for adults with primary disease is either 140 mg every two weeks or 420 mg (the contents of three pre-filled­ syringes) once a month; both doses are clinically­ equivalent­. For adults or children older than 12 years with homozygous­ FH, the initial recommende­d dose is 420 mg once a month. If a response is not achieved after 12 weeks of treatment,­ the dose can be increased up to 420 mg every two weeks. For more informatio­n, see the package leaflet.  

die Aktie gefällt mir,  

...
nur der Kurs macht mir Sorgen.

Spaß beiseite;
Zieht der TecDax weiter an, wird auch Evotec nachziehen­.  

Guten Morgen liebe Börsianer
und liebe Jungbörsia­ner und liebe angehende Börsianer :-)

Evotec zeigt Stärke,

gut für einen Trade  

@all Evotec nächstes Ziel 3,70 Euro
TDAX long

Evotec long ;-)  

Ziel 4:50€ 3,85€ erstmal Hürde nehmen  

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