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Biotech / Medical : Regeneron Pharmaceuticals
REGN 784.45-0.4%Nov 26 3:59 PM EST

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From: Biotech Jim5/22/2015 8:58:54 AM
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Amgen Receives Positive CHMP Opinion For Use Of Repatha™ (Evolocumab) For The Treatment Of High Cholesterol

First Positive Regulatory Agency Determination for a PCSK9 Inhibitor

finance.yahoo.com

"The CHMP recommended granting Repatha marketing authorization 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."
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