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Tuesday, 26 May 2015

European Medicines Agency approves Amagens PCSK9 inhibitor Repatha

On 21 May 2015, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for themedicinal product Repatha, intended for the treatment of adult patients with hypercholesterolaemia and mixed dyslipidaemia, and adults and adolescents aged 12 years and over with homozygous familial hypercholesterolaemia.

The applicant for this medicinal product is Amgen Europe B.V.

Repatha will be available as 140 mg/ml solution for injection in pre-filled syringe or in pre-filled pen. The active substance of Repatha is evolocumab, a lipid modifying agent (ATC code: C10AX13).

Evolocumab, a human monoclonal antibody, binds selectively to proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that regulates the recycling of LDL-receptors on the surface of liver cells and decreases the ability of the liver to clear LDL from the blood. By binding to PCSK9 evolocumab increases liver levels of LDL receptor thereby reducing serum LDL-cholesterol levels.

The benefits with Repatha are its ability to reduce the level of serum LDL-cholesterol in patients who are unable to control their cholesterol despite taking maximum tolerated dose of statins or who cannot take statins.

The most common side effects are: nasopharyngitis, upper respiratory tract infection, headache and back pain. The use of Repatha may lead to very low cholesterol levels where safety has not yet been established.

I've also seen that neurocognitive problems can occur with those taking this latest money spinner from Big Pharma! 


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