Evolocumab (trade name Repatha) is a monoclonal antibody that is a immunotherapy medication for the treatment of hyperlipidemia. (wikipedia.org)
LONDON, UK - Evolocumab ( Repatha , Amgen), an investigational human monoclonal antibody for proprotein convertase subtilisin-kexin type 9 (PCSK9), is one step closer to being available in Europe [ 1 ] . (medscape.com)
Abstracts include data evaluating Repatha ® (evolocumab), a proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitor for the treatment of patients with high cholesterol, across ESC/European Atherosclerosis Society (EAS) cardiovascular risk subgroups, as well as the long-term efficacy and safety of Repatha treatment in patients with the genetic condition heterozygous familial hypercholesterolemia (HeFH). (prnewswire.com)
PCSK9 inhibitors, such as alirocumab (Praluent) and evolocumab (Repatha). (nih.gov)
THOUSAND OAKS, Calif. , Aug. 22, 2022 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the presentation of eight cardiovascular (CV) scientific research abstracts, including long-term and real-world evidence studies that add to the robust body of evidence demonstrating the efficacy and safety profile of Repatha ® (evolocumab). (amgen.com)
THOUSAND OAKS, Calif., Feb. 21, 2017 -- (Healthcare Sales & Marketing Network) -- Amgen (AMGN) today announced that the European Commission (EC) has adopted a decision to change the Repatha (evolocumab) marketing authorization, approving a new single-dose delivery option. (salesandmarketingnetwork.com)
Amgen (NASDAQ:AMGN) today announced top-line results from two Repatha® (evolocumab) open label extension (OLE) studies to the Phase 3 FOURIER cardiovascular outcomes trial. (industryintel.com)
Patients with a history of a serious hypersensitivity reaction to evolocumab or any of the excipients in REPATHA. (nih.gov)
Repatha ( evolocumab ) is an injectable prescription medication used to lower LDL cholesterol (sometimes called "bad cholesterol")-including high LDL levels caused by heterozygous familial hypercholesterolemia -in adults and children 10 years and older. (my.id)
Evolocumab (Repatha) for Heart Disease - The FOURIER Trial - Success or Failure? (docsopinion.com)
The goal of FOURIER was to evaluate the efficacy and safety of evolocumab (Repatha), a PCSK9 inhibitor, among subjects with elevated risk on statin therapy. (docsopinion.com)
In 2015, FDA approved evolocumab (Repatha ®), a human monoclonal antibody of the PCKSK9 (proprotein convertase subtilisin kexin type 9) inhibitor class. (rhochistj.org)
Repatha ® (evolocumab) sales growth was driven by higher unit demand. (amgen.com)
Biologics' introduction into commercial use is not without its disappointments: Repatha (evolocumab) and Praluent (alirocumab) cholesterol treatments based on monoclonal antibodies, introduced with much fanfare (and concern over their cost) last year, represented less than 0.001% of the market at the end of the year, as most prescribers stuck with the older statin drugs, which are now almost entirely off-patent. (pharmaceuticalcommerce.com)
Statin therapy4
The Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk (FOURIER) study is a 22,500-patient trial testing evolocumab against statin therapy for the reduction of the primary composite end point of cardiovascular death, MI, hospitalization for unstable angina , stroke , or coronary revascularization. (medscape.com)
The YUKAWA-2 trial evaluated safety, tolerability and efficacy of evolocumab compared to placebo in combination with statin therapy in 404 Japanese patients with high cardiovascular risk and high cholesterol. (prnewswire.com)
FOURIER (20110118) was a randomized placebo-controlled study of evolocumab, in patients with clinically evident atherosclerotic CVD on stable effective statin therapy. (industryintel.com)
1 Evolocumab is used to treat adult patients with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease who need further lowering of their LDL-C levels, while being on maximum tolerated statin therapy. (rhochistj.org)
Efficacy7
In a press release, the EMA said the positive review from CHMP is based on the efficacy of evolocumab for lowering LDL-cholesterol levels in nine studies of patients with hypercholesterolemia/mixed dyslipidemia and in two studies of patients with homozygous FH. (medscape.com)
On June 10, 2015, an advisory committee from the US Food and Drug Administration will evaluate the safety and efficacy data for evolocumab and make its own recommendation about the drug's availability stateside. (medscape.com)
Association Between Circulating Baseline Proprotein Convertase Subtilisin Kexin Type 9 Levels and Efficacy of Evolocumab. (nih.gov)
The approval is based on data from the HAUSER-RCT phase 3b study, which evaluated the safety and efficacy of evolocumab in pediatric patients between 10 and 17 years of age who were diagnosed with HeFH. (pharmacytimes.com)
Evolocumab still needs to be monitored for its efficacy in patients and their quality of life. (rhochistj.org)
This open-label extension study aimed to evaluate the long-term safety and efficacy of evolocumab up to 52 weeks in PWH. (unige.it)
Efficacy and Safety of the PCSK9 Inhibitor Evolocumab in Patients with Mixed Hyperlipidemia. (ox.ac.uk)
Praluent1
The day prior, the same FDA advisory committee will evaluate alirocumab ( Praluent , Sanofi/Regeneron Pharmaceuticals), another PCSK9 inhibitor similar to evolocumab that is currently being reviewed by European regulatory authorities. (medscape.com)
Injection17
The FDA approved evolocumab injection on 27 August 2015, for some patients who are unable to get their LDL cholesterol under control with current treatment options. (wikipedia.org)
Evolocumab injection is used to reduce the risk of a stroke or heart attack or the need for coronary artery bypass (CABG) surgery in people with cardiovascular disease. (medlineplus.gov)
Evolocumab injection is in a class of medications called proprotein convertase subtilisin kexin type 9 (PCSK9) inhibitor monoclonal antibody. (medlineplus.gov)
Evolocumab injection comes as a solution (liquid) in a prefilled syringe, a prefilled autoinjector, and in an on-body infusor with a prefilled cartridge to inject subcutaneously (just under the skin). (medlineplus.gov)
When evolocumab injection is used to treat HeFH or cardiovascular disease or to reduce the risk of a stroke, heart attack, and coronary artery bypass surgery, it is usually injected every 2 weeks or once every month. (medlineplus.gov)
When evolocumab injection is used to treat HoFH, it is usually injected once every month. (medlineplus.gov)
Use evolocumab injection exactly as directed. (medlineplus.gov)
If you are using evolocumab injection once every month (420 mg dose), inject it once over 9 minutes with the on-body infusor and prefilled cartridge for each injection or inject 3 separate injections one after the other within 30 minutes, using a different prefilled syringe or prefilled autoinjector for each injection. (medlineplus.gov)
Evolocumab injection helps to control cholesterol levels and reduce the risk of a stroke, heart attack, or coronary artery bypass surgery, but it does not cure these conditions or eliminate these risks. (medlineplus.gov)
Continue to use evolocumab injection even if you feel well. (medlineplus.gov)
Do not stop using evolocumab injection without talking to your doctor. (medlineplus.gov)
Evolocumab injection comes in a prefilled autoinjector, prefilled syringes, and in an infusor with a prefilled cartridge that contain enough medication for one dose. (medlineplus.gov)
You can inject evolocumab injection under the skin on your thighs or stomach area, except for the 2-inch area around your navel (belly button). (medlineplus.gov)
Do not inject evolocumab injection into a spot that is tender, bruised, red, or hard. (medlineplus.gov)
These instructions describe how to inject a dose of evolocumab injection. (medlineplus.gov)
Whether you're looking for Jevtana Injection, Evolocumab Solution For Injection, jevtana injection etc, you can explore and find the best products from Tradeindia. (tradeindia.com)
The common adverse effects of evolocumab include nasopharyngitis, upper respiratory tract infection, influenza, back pain, and injection site reactions that result in redness and itching at where the injection was administered 1 . (rhochistj.org)
Heterozygous familial1
Monthly treatment with evolocumab reduced LDL-C by a mean of 38% from baseline compared to placebo among patients ages 10 to 17 with heterozygous familial hypercholesterolemia. (pharmacytimes.com)
Inhibitors4
FDA has approved two cholesterol-lowering drugs in a class of biologics known as PCSK9 inhibitors: alirocumab and evolocumab. (fda.gov)
In recent years, two new drugs were approved for patients who are unable to reduce circulating LDL-C with the current therapies: evolocumab and alirocumab (proprotein convertase subtilisin/kexin type nine [PCSK9] inhibitors). (springer.com)
There were 269 (176 evolocumab, 93 alirocumab) new users of PCSK9 inhibitors. (springer.com)
The studies, ' Ocular Disorders Associated With PCSK9 Inhibitors: A Pharmacovigilance Disproportionality Analysis ' and ' Adverse Event Profiles of PCSK9 Inhibitors Alirocumab and Evolocumab: Data Mining of the FDA Adverse Event Reporting System ' were published online in the British Journal of Clinical Pharmacology . (hcplive.com)
Amgen2
Amgen submitted a biologics license application (BLA) for evolocumab to the FDA in August 2014. (wikipedia.org)
We are encouraged by the evolocumab data from the YUKAWA-2 study in the Japanese patient population and the remarkable consistency we have seen across our clinical program," said Sean E. Harper , M.D., executive vice president of Research and Development at Amgen. (prnewswire.com)
Alirocumab and evolocumab2
The study results showed clear dose-response for alirocumab and evolocumab on the PD biomarkers, meaning that there was a larger change in LDL-C and apoB from baseline as doses increased. (fda.gov)
LDL-C and apoB may be suitable PD biomarkers in PD similarity studies of alirocumab and evolocumab. (fda.gov)
Monoclonal4
Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). (wikipedia.org)
Evolocumab is a human monoclonal antibody to PCSK9 (proprotein convertase subtilisin/kexin type 9), a circulating protein that modulates the activity of the LDL cholesterol receptor in the liver. (nih.gov)
Impact of Target-Mediated Elimination on the Dose and Regimen of Evolocumab, a Human Monoclonal Antibody Against Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9). (nih.gov)
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood. (prnewswire.com)
Subcutaneous evolocumab2
Patients were randomized to one of eight treatment groups to compare subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) with subcutaneous placebo (every two weeks or monthly) when added to different daily doses of atorvastatin. (prnewswire.com)
Design: This final analysis of a multinational, placebo-controlled, double-blind, randomized phase 3 trial evaluated the effect of monthly subcutaneous evolocumab 420 mg on low-density lipoprotein cholesterol (LDL-C) during the open-label period (OLP) following 24 weeks of double-blind period in PWH with hypercholesterolemia/mixed dyslipidemia. (unige.it)
Placebo12
The percent reduction in LDL-C, or "bad" cholesterol, was clinically meaningful, statistically significant, and consistent with the results observed for the same doses in the Phase 2 YUKAWA trial for evolocumab compared to placebo. (prnewswire.com)
Patients continuing in the study at completion of lipid stabilization were then randomized to one of four treatment arms: evolocumab 140 mg every two weeks, evolocumab 420 mg monthly, subcutaneous placebo every two weeks, or subcutaneous placebo monthly. (prnewswire.com)
According to the press release, 53 patients received a placebo and 104 patients received 420 mg of evolocumab. (pharmacytimes.com)
According to the press release, monthly treatment with evolocumab reduced LDL-C by a mean of 38% from baseline compared to placebo, which showed that the study met its primary endpoint. (pharmacytimes.com)
Patients who received evolocumab had improved secondary lipid parameters from baseline compared to placebo, including a 35% reduction in non-high-density lipoprotein cholesterol (non-HDL-C), a 27% reduction in total cholesterol, and a 32% reduction in apolipoprotein B at week 24. (pharmacytimes.com)
Patients with established cardiovascular disease were randomized to evolocumab 140 mg subcutaneous every two weeks or 420 mg monthly versus placebo. (docsopinion.com)
The study found that evolocumab lowered LDL cholesterol levels by 59% compared with placebo. (docsopinion.com)
There was no significant difference between evolocumab and placebo with regard to adverse events. (docsopinion.com)
A total of 27.564 were randomized to either evolocumab (13.784) or placebo (13.780). (docsopinion.com)
It was estimated that 1.630 such end-point events were required to provide a 90% power to detect a 15% relative reduction with evolocumab as compared with placebo. (docsopinion.com)
Evolocumab also reduced triglycerides, atherogenic lipid parameters (non-HDL-C, apolipoprotein B, total cholesterol, very-low-density lipoprotein cholesterol, and lipoprotein[a]), and increased HDL-C. TEAEs were similar between placebo and evolocumab during the OLP. (unige.it)
Treatment differences for evolocumab vs. placebo and ezetimibe followed a similar pattern for non-high-density lipoprotein (HDL-C) and apolipoprotein B. Evolocumab was well tolerated, with balanced rates of adverse events leading to discontinuation of evolocumab vs. comparator (placebo and/or ezetimibe). (ox.ac.uk)
Cardiovascular disease2
Long-Term Evolocumab in Patients With Established Atherosclerotic Cardiovascular Disease. (nih.gov)
Michelle DeSanti Biology 22 (24556) Professor Linder 4 May 2017 Clinical outcomes: Evolocumab use for Cardiovascular Disease High cholesterol, two words that can certainly ignite a fear in a patient who is newly diagnosed with this common issue. (cram.com)
Hyperlipidemia2
CONCLUSION: The significant reductions of atherogenic lipids including LDL-C, non-HDL-C, and apolipoprotein B seen with evolocumab are similar in patients with and without mixed hyperlipidemia. (ox.ac.uk)
34. Evolocumab as treatment in lorlatinib-related hyperlipidemia. (nih.gov)
Statins2
Statins are an important therapy for patients with high cholesterol and adding evolocumab may help lower their LDL cholesterol levels when statins are not sufficient. (prnewswire.com)
Unlike statins, there is no proven benefit with evolocumab in preventing cardiovascular events such as strokes or heart attacks 2 . (rhochistj.org)
Patients5
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approving evolocumab as an adjunct to diet in patients with elevated cholesterol levels who are unable to reach their recommended LDL-cholesterol goal despite taking an optimal dose of statin. (medscape.com)
Patients deemed statin intolerant or those in whom a statin is contraindicated would also be eligible for treatment with evolocumab. (medscape.com)
The new data from ORION-3 study included findings from 92 patients first treated with evolocumab injections every 2 weeks for a year, an intervention that lowered their LDL-C levels by an average of about 60%, compared with their pretreatment level. (medscape.com)
The authors estimate that 74 patients would need to be treated with evolocumab for 2 years to prevent one cardiovascular death, myocardial infarction or stroke. (docsopinion.com)
Characteristics of patients prescribed Evolocumab in Europe, Does clinical use match clinical guidelines? (escardio.org)
FOURIER2
FOURIER-OLE (Further cardiovascular OUtcomes Research with PCSK9 Inhibition in Subjects with Elevated - Risk-Open Label Extension) were multicenter, open-label extension (OLE) studies designed to assess the extended long-term safety of evolocumab in subjects who completed the FOURIER study (20110118). (industryintel.com)
The FOURIER-OLE is composed of studies 20130295 and 20160250, which enrolled 5,035 and 1,600 subjects who completed FOURIER study (20110118) to receive open-label evolocumab and were followed up for a median of 5 and 4.6 years, respectively. (industryintel.com)
Inhibitor1
Since evolocumab is a PCSK9 inhibitor, it blocks the effects of PCSK9 and prevents the degradation of LDL receptors 1 . (rhochistj.org)
Dose1
Results: Of the 467 participants randomized in the double-blind period, 451 (96.6%) received at least one dose of evolocumab during the OLP (mean age of 56.4 years, 82.5% male, mean duration with HIV of 17.4 years). (unige.it)
Clinical1
The authors highlight the possibility that the full clinical benefit of evolocumab may take longer than 2-3 years to develop. (docsopinion.com)
Reduction1
Chief among the benefits was a reduction in cardiovascular mortality not observed in the pivotal trial that led to U.S. approval of evolocumab. (the-hospitalist.org)
Therapy1
Evolocumab therapy has been associated with a low rate of serum aminotransferase elevations and has yet to be linked to instances of clinically apparent acute liver injury. (nih.gov)
Approval2
Evolocumab received approval from Health Canada on September 10, 2015. (wikipedia.org)
Cite this: EMA Committee Recommends Approval of Evolocumab - Medscape - May 22, 2015. (medscape.com)
Adverse events1
Conclusion: Long-term administration of evolocumab lowered LDL-C and non-HDL-C, allowing more PWH to achieve recommended lipid goals with no serious adverse events. (unige.it)
Safety1
Both investigator groups found the relative lack of ocular effects and the general safety profiles were similar for evolocumab and alirocumab. (hcplive.com)
Secondary1
Evolocumab reduced the primary and secondary composite end points by 15% and 20% respectively. (docsopinion.com)
Human3
After washing and blocking with PBST + 5% BSA, detection was performed using HRP conjugated Human Anti-Evolocumab Antibody, clone AbD40406ia (HCA377) at a concentration of 2 μg/ml in HISPEC Assay Diluent ( BUF049A ) followed by QuantaBlu Fluorogenic Peroxidase Substrate. (bio-rad-antibodies.com)
A microtiter plate was coated overnight with evolocumab, human PCSK9, human IgG1 kappa or human IgG1 lambda at a concentration of 5 µg/ml. (bio-rad-antibodies.com)
After washing and blocking with PBST + 5% BSA, detection was performed using HRP conjugated Human Anti-Evolocumab Antibody, clone AbD40406ia (HCA377) titrated to the given concentrations in HISPEC Assay Diluent ( BUF049A ) followed by QuantaBlu Fluorogenic Peroxidase Substrate. (bio-rad-antibodies.com)
Levels1
Although evolocumab is effective at reducing of LDL-C levels in the blood, its effects on reducing morbidity and mortality are still in question 1 . (rhochistj.org)