European drug market entries 2015 with new mechanisms of action. By clicking send, you acknowledge that you have permission to email the recipient with this information. PMID: 27697814. , proprotein convertase subtilisin/kexin type 9 (PCSK9), "Repatha- evolocumab injection, solution Repatha- evolocumab kit", "International Nonproprietary Names for Pharmaceutical Substances (INN). The judge gave Regeneron and Sanofi 30 days to appeal before the injunction went into effect. Individual plans may vary Diseases & Conditions, encoded search term (evolocumab (Repatha)) and evolocumab (Repatha), AACE Issues 'Cookbook' Algorithm to Manage Dyslipidemia, Evolocumab Safe and Effective in Pediatric FH, FOURIER: Evolocumab Follow-up Shows No Cognitive Adverse Effects, Pesco-Mediterranean Diet, Fasting 'Ideal' to Reduce CVD, Chili Pepper Consumption Linked to Better Midlife Survival, New ESC/EACTS Guideline on Atrial Fibrillation, Proinflammatory Dietary Pattern Linked to Higher CV Risk, First-of-Its Kind Guideline on Lipid Monitoring in Endocrine Diseases, Women With Heterozygous FH Less Likely to Receive Treatment. Adding plans allows you to compare formulary status to other drugs in the same class. Mechanism of action. Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation. Pharmacotherapeutic group: Other lipid modifying agents.ATC code: C10AX13. Increasing liver LDLR levels results in associated reductions in serum LDL-cholesterol (LDL-C). Repatha (Evolocumab): Second PCSK9 Inhibitor Approved by the FDA for Patients with Familial Hypercholesterolemia. Monoclonal antibody that binds to PCSK9 (proprotein convertase subtilisin/kexin type 9) LDL-C is cleared from the circulation preferentially through the LDL receptor (LDLR) pathway. MECHANISM OF ACTION. The above information is provided for general commonly, these are "non-preferred" brand drugs or specialty Most van den Heuvel TW, Cohen AF, Rissmann R. Clin Med (Lond). Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin type 9 (PCSK9). Proposed INN: List 108", "PCSK9 инхибитори – нов клас медикаменти за лечение на дислипидемия | Списание МД", Amgen Submits Biologics License Application For Novel Investigational LDL Cholesterol-Lowering Medication Evolocumab To The FDA, "FDA approves Repatha to treat certain patients with high cholesterol", European Commission Approves Amgen's New Cholesterol-Lowering Medication Repatha™ (evolocumab), The First PCSK9 Inhibitor To Be Approved In The World, For Treatment Of High Cholesterol, "Regulatory Decision Summary (SBD): REPATHA - 2015 - Health Canada", "Amgen Wins Ban on Sanofi's Praluent Cholesterol Drug Sales", "Evolocumab and Clinical Outcomes in Patients with Cardiovascular Disease", "Cost-effectiveness of PCSK9 Inhibitor Therapy in Patients With Heterozygous Familial Hypercholesterolemia or Atherosclerotic Cardiovascular Disease", "The bigger message behind Amgen's decision to slash cost of its Repatha cholesterol drug", Magnesium pyridoxal 5-phosphate glutamate, https://en.wikipedia.org/w/index.php?title=Evolocumab&oldid=984628172, Chemicals that do not have a ChemSpider ID assigned, Chemical pages without DrugBank identifier, Articles containing unverified chemical infoboxes, Creative Commons Attribution-ShareAlike License, This page was last edited on 21 October 2020, at 04:42. This website also contains material copyrighted by 3rd parties. PCSK9 binds to LDLR on the hepatocyte surface to promote LDLR degradation within the liver. ... 12.1 Mechanism of Action 12.2 Pharmacodynamics 12.3 Pharmacokinetics 13 NONCLINICAL TOXICOLOGY 13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility 13.2 Animal Toxicology and/or Pharmacology 14 CLINICAL STUDIES 14.1 Prevention of Cardiovascular Events Mechanism of action Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation. commonly, these are "preferred" (on formulary) brand drugs. Repatha ® helps the liver clear LDL bad cholesterol by limiting the actions of a protein called PCSK9—and less PCSK9 means less LDL in your blood. Repatha’s mechanism of action, dosage and administration Repatha contains an active ingredient called evolocumab, a human monoclonal antibody that inhibits the PCSK9 (proprotein convertase subtilisin/kexin type) protein, which reduces the liver’s ability to remove LDL from the blood. Mechanism. Evolocumab (trade name Repatha) is a monoclonal antibody medication designed for the treatment of hyperlipidemia. Mechanism of Action . Manage and view all your plans together – even plans in different states. The recipient will receive more details and instructions to access this offer. Evolocumab (trade name Repatha) is a monoclonal antibody medication designed for the treatment of hyperlipidemia. and formulary information changes. MECHANISM OF ACTION.  Evolocumab received approval from Health Canada on September 10, 2015.  It is made by Amgen. commonly, these are "non-preferred" brand drugs. CLINICAL PHARMACOLOGY Mechanism of Action Evolocumab is a human monoclonal IgG2 directed against human proprotein convertase subtilisin kexin 9 … Increasing liver LDLR levels results in associated …  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. provider for the most current information. Contact the applicable plan Most View the formulary and any restrictions for each plan. 2500032-overview https://profreg.medscape.com/px/getpracticeprofile.do?method=getProfessionalProfile&urlCache=aHR0cHM6Ly9yZWZlcmVuY2UubWVkc2NhcGUuY29tL2RydWcvcmVwYXRoYS1ldm9sb2N1bWFiLTEwMDAwMDI=, View explanations for tiers and PCSK9 is a protein that targets LDL receptors for degradation and thereby reduces the liver's ability to remove LDL-C, or "bad" cholesterol, from the blood. informational and educational purposes only. REPATHA is a sterile, preservative-free, clear to opalescent, colorless to pale yellow solution for subcutaneous administration. Evolocumab is a fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Evolocumab is a human monoclonal IgG2 antibody that binds to and inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9) binding to low-density lipoprotein receptors (LDLR). One article calculated this to be about $400,000 to $500,000 per quality-adjusted life year (QALY), which did not meet "generally accepted" cost-benefit thresholds. Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature. Compare formulary status to other drugs in the same class. This drug is available at the lowest co-pay. This drug is available at a higher level co-pay. Take Action HOW DOES REPATHA ® WORK? PCSK9 is a serine protease that destroys LDLR in the liver, resulting in decreased LDL-C clearance and increased plasma LDL-C Evolocumab binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. Similar articles. Pharmacology: Pharmacodynamics: Mechanism of action: Evolocumab binds selectively to PCSK9 and prevents circulating PCSK9 from binding to the low density lipoprotein receptor (LDLR) on the liver cell surface, thus preventing PCSK9-mediated LDLR degradation. Repatha Mechanism of Action. restrictions. Distributor: Zuellig Pharma. This drug is available at a middle level co-pay. Repatha significantly reduced TC, ApoB, non-HDL-C, TC/HDL-C, ApoB/ApoA1, and Lp(a) from baseline to mean of weeks 10 and 12 compared with both placebo and ezetimibe (p < 0.001) (see Table 2). , Results of the FOURIER trial were published in March 2017. PCSK9 binds to LDLR on the hepatocyte surface to promote LDLR degradation within the liver.  The European Commission approved it in July 2015. 2016 Oct;16(5):475-480.  Amgen reported approval by Health Canada in a press release on September 15, 2015. This enzyme attaches to cholesterol receptors on the surface of liver cells and causes these receptors to … Most If you log out, you will be required to enter your username and password the next time you visit. 140mg/mL in a single-use prefilled syringe OR single-use SureClick autoinjector, 420mg/3.5mL in a single-use Pushtronex system (on-body infusor with prefilled cartridge), Mild or moderate: No dose adjustment required, Severe or end-stage renal disease (ESRD): In a clinical trial, reductions in PCSK9 levels in patients with severe renal impairment or ESRD receiving hemodialysis was similar to those with normal renal function, No effects on pregnancy or neonatal/infant development when monkeys were subcutaneously administered evolocumab from organogenesis through parturition at dose exposures up to 12 times the exposure at the maximum recommended human dosage, In a similar study with another drug in the PCSK9 inhibitor antibody class, humoral immune suppression was observed in infant monkeys exposed to that drug in utero at all doses, Drug appears cloudy or discolored, or contains particles, The orange cap is missing or not securely attached, Self-injection: Thigh or abdomen (except for a 2-inch area around the naval), Caregiver: Thigh, abdomen, or outer area of upper arm, Dose missed within 7 days: Administer dose and start a new schedule based on this date, 140 SC q2week dose: Wait until the next dose on the original schedule, 420 mg SC once monthly: Administer dose and start a new schedule based on this date.