Tuesday, July 21, 2015
News, Opinions & Interviews
NEWS - AMGEN - EU - EVOLOCUMAB APPROVED
Authority was granted by the EU following positive recommendation for Medicinal Products for Humans (CHMP) of the European Medicines Agency (EMA), to sell EVOLOCUMAB to patients with uncontrollable cholesterol and those who need additional intensive reduction of LDL.
With this approval, evolocumab is indicated for the treatment of adults with primary hypercholesterolemia, such as heterozygous (HeFH) familial hypercholesterolaemia and mixed dyslipidaemia. In this setting, the drug, which is given as an injection every 2 weeks or once monthly, is approved for patients currently taking a maximally tolerated statin or other lipid-lowering therapies but unable to achieve sufficient LDL lowering or get to treatment goals.
The drug also received an indication for use in patients unable to tolerate statins and for use in whom a statin is contraindicated. Importantly it is also approved for use in combination with statins and other lipid-lowering medication in adults AND adolescents (12 years or older) with homozygous (HoFH) FH.
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