Summary of the risk management plan (RMP) for Praluent (Alirocumab)
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1 EMA/519153/2015 Summary of the risk management plan (RMP) for Praluent (Alirocumab) This is a summary of the risk management plan (RMP) for Praluent, which details the measures to be taken in order to ensure that Praluent is used as safely as possible. For more information on RMP summaries, see here. This RMP summary should be read in conjunction with the EPAR summary and the product information for Praluent, which can be found on Praluent s EPAR page. Overview of disease epidemiology Praluent, which contains the active substance alirocumab, is a medicine used to treat adults with primary emia (high blood cholesterol levels, in particular LDL-cholesterol or bad cholesterol). It is used in combination with other lipid-lowering therapies, or alone in patients not tolerating such therapy. Primary means that the disease is generally the result of a genetic abnormality. Primary emia includes heterozygous familial (when the genetic abnormality is inherited from only one parent or hefh) and non-familial disease (when the genetic abnormality arises by chance without a family history, non-fh). Between 2 and 5 out of 1000 European citizens are believed to be affected. Praluent is also used to treat mixed dyslipidaemia (abnormal levels of fats in blood, including high levels of LDL-cholesterol). Summary of treatment benefits Praluent has been studied in 10 main studies involving over 5,000 adult patients with emia (including patients with heterozygous familial disease) and mixed dyslipidaemia. Some studies looked at Praluent taken on its own, while others studied Praluent in combination with other fat-lowering medicines, including patients on the maximum recommended doses of statins. Some studies compared Praluent with placebo (a dummy treatment) and others to another medicine for emia (ezetimibe). These studies showed that when Praluent was given on top of a statin it led to a substantial reduction in blood levels of LDL-cholesterol (between 39 and 62% more than placebo) after 6 months of treatment. When given on top of standard treatment or on top of placebo, Praluent produced a 24 to 36% greater reduction in blood levels of LDL-cholesterol than ezetimibe. Unknowns relating to treatment benefits Praluent has not yet been evaluated in children or adolescents. In addition, treatment benefits are unknown in patients with homozygous familial hypercholesterolemia (HoFH, a severe form of the disease), since they were not part of the involved in the clinical studies. Page 1/9
2 Summary of safety concerns Important identified risks Risk What is known Preventability Ability of the medicine to trigger an immune response (Immunogenicity) General allergic/hypersensitivity reactions after being given the medicine (Systemic hypersensitivity reactions) As with any medicine that is a protein (e.g. monoclonal antibody) there is a potential for the body to make antibodies against Praluent, which could cause Praluent not to work. In clinical studies, development of antibodies against Praluent was observed in a small number of patients, usually without other signs or symptoms. Praluent may rarely cause hives (urticaria) or hypersensitivity vasculitis (a hypersensitivity reaction whose symptoms include diarrhoea, rash, or purple-coloured spots on the skin known as purpura). Reddish skin spots, sometimes with blisters (nummular eczema) are also rarely reported. Unknown Patients should avoid taking Praluent in case of known allergic reaction to alirocumab or to any of its other ingredients. Important potential risks Risk Blurred vision linked to cataracts (loss of transparency of the lens of the eye) in patients with very low levels of cholesterol in the blood What is known Cases of cataract have been diagnosed more frequently in patients treated with alirocumab than in those treated with placebo, when they had very low cholesterol blood levels. (Cataract (in the context of very low LDL-Cholesterol))* Problems with mental function (Neurocognitive disorders) Cases of abnormal cognitive (mental) function, such as memory impairment, have been reported with similar incidence in patients given alirocumab and placebo in the clinical studies. * ie, less than 25 mg/dl (0.65 mmol/l) Page 2/9
3 Missing information Risk Use in children and adolescents Use in pregnant and breastfeeding women Use in patients with severe problems with the liver What is known Praluent has not been evaluated in children or adolescents. Praluent is not recommended during pregnancy or breastfeeding. Praluent has not been evaluated in pregnant or breastfeeding women. Although Praluent passed from the blood supply of the mother to the unborn baby in animal studies, it had no harmful effects on the offspring. As it is unknown whether Praluent passes to human milk, the doctor should consider advising the woman to discontinue breastfeeding or to stop taking the medicine. Praluent has not been evaluated in patients with severe liver disease. Praluent was evaluated in subjects with mild and moderate reduction in liver function and there was no effect on the medicine s concentration in blood. (Use in severe hepatic impairment) Use in patients infected with hepatitis C Praluent has not been evaluated in patients infected with hepatitis C. (Use in chronic HCV carrier/hepatitis) Long-term use (above 5 years) Clinical impact of very low LDL-cholesterol for extended period of time Influence of Praluent on sex hormones in men and women Chronic use for up 18 months has been extensively evaluated. The evaluation of the use of Praluent for up to 5 years is. Praluent has not been evaluated for longer than 5 years. As mentioned above, cataracts have been diagnosed more frequently in patients treated with alirocumab than placebo, when they had very low cholesterol blood levels. Other clinical impact of very low LDL-C is unknown at this stage. Some cholesterol is used by the body to make other substances, including sex hormones. Limited information is available on the influence of Praluent on sexual hormones in men and women. (Influence of alirocumab on gonadal steroid hormones and gonadotropins (in men and women)) * ie, less than 25 mg/dl (0.65 mmol/l) Summary of risk minimisation measures by safety concern All medicines have a summary of product characteristics (SmPC) which provides physicians, pharmacists and other healthcare professionals with details on how to use the medicine, and also describes the risks and recommendations for minimising them. Information for patients is available in Page 3/9
4 lay language in the package leaflet. The measures listed in these documents are known as routine risk minimisation measures. The SmPC and the package leaflet are part of the medicine s product information. The product information for Praluent can be found on Praluent s EPAR page. This medicine has no additional risk minimisation measures. Planned post-authorisation development plan List of studies in post-authorisation development plan Study/activity LTS11717 Long-term safety 150 weeks in patients with non-fh or hefh at high cardiovascular risk not adequately a statin with or without other lipid modifying therapies (LMTs). Long-term safety 27-May-2015 EFC12492 (FH I) patients with hefh not adequately statin with or without other LMTs. 27-May-2015 CL-1112 (FH II) patients with hefh not adequately statin with or without other LMTs. 15-Sep-2015 Page 4/9
5 EFC12732 (HIGH FH) 150 weeks in patients with hefh not adequately statin with or without other LMTs and with LDL-C 160 mg/dl (4.14 mmol/l) or more. 17-Sep-2015 CL-1308 (CHOICE I) 300 mg every 4 weeks or 75/150 mg every two weeks versus placebo in patients with emia at moderate to very high cardiovascular risk, not adequately LMT. 15-Nov-2015 EFC11569 (COMBO II) patients at high cardiovascular risk with emia not adequately statin therapy. 27-Jan-2016 EFC13672 versus placebo in Japanese patients with hefh or high Japanese 29-Jan-2016 Page 5/9
6 cardiovascular risk patients with emia not adequately LMT. PDY13670 Pharmacodynamic effect of repeated doses of alirocumab every two weeks on lipids and lipoprotein metabolism. 26-Aug-2016 EFC13786 (CHOICE II) 150 mg every four weeks or 75/150 weeks versus placebo in patients with emia not treated with statin. 26-Jun-2015 LTS13463 (OLE of hefh studies) Open-label extension study of FH I, FH II, HIGH FH, and LTS11717 to assess longterm safety and efficacy of alirocumab patients with hefh. 03-Jan-2018 OLE of CL-1119 (ALTERNATIVE) statin intolerant patients with 10-Mar-2017 Page 6/9
7 primary emia (hefh and non-fh) at moderate or high cardiovascular risk. CL-1018 (OLE study of the GOF study) Open-label extension study to CL-1018 study to assess the longterm efficacy and safety of alirocumab 150 weeks in patients with autosomal dominant emia (up to 36- month duration). 10-Mar-2017 CL-1032 (OLE of R727-CL-1003) Open-label extension study to CL-1003 to assess long-term safety and tolerability of alirocumab 150 weeks in patients with hefh receiving concomitant statins with or without other LMTs (up to 48- month duration). 10-Mar-2017 OLE of EFC13786 (CHOICE II) Open-label extension study of CHOICE II to assess long-term efficacy and safety 150 mg every four weeks or 75/ Jan-2018 Page 7/9
8 weeks versus placebo in patients with emia not treated with a statin. EFC11570 (CV OUTCOMES) Effect of alirocumab (75 mg/ml or 150 mg/ml, every two weeks ) versus placebo on the occurrence of cardiovascular events in patients who had recently experienced an acute coronary syndrome (up to 64-month duration). Long-term Efficacy and safety of alirocumab in 28-Jul-2018 LTS14580 (post- ODYSSEY OUTCOMES registry study (PASS) prospective observational study) - Evaluate safety in long-term use (more than 5 years). - Evaluate potential clinical impact of very low LDL-C for extended period of time. - Specific (mental function) evaluation. - Influence of alirocumab on gonadal steroid hormones and gonadotropins (in men and women). Safety in longterm use (more than 5 years) Clinical impact of very low LDL-C for extended period of time Neurocognitive disorders Measurement of gonadal steroid hormones and gonadotropins (in men and women) Q (Final report) Page 8/9
9 A PASS in patients infected with HIV Gather relevant safety data in patients infected with HIV. Safety data in patients infected with HIV planned Q (Protocol submission) A trial in which there will be a dedicated prospective assessment of function Prospective assessment of (mental) function using a battery of tests. Evaluate disorders as potential risk planned Q (Protocol submission) Drug utilization survey To assess the effectiveness of dosing recommendation as per the product information. LDL-cholesterol levels in respect to dosing recommendation planned Q (Protocol submission) Studies which are a condition of the marketing authorisation None of the studies in the previous section are a condition of the marketing authorization for Praluent. Summary of changes to the risk management plan over time Not applicable. This summary was last updated in Page 9/9
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