Pain in your back, shoulder, legs, or arms. and ezetimibe or bempedoic acid, 100 patients in each of these groups would provide 95% or greater power to detect such a difference at an alpha level of 0.05 using a two-sided t-test. The first thing we need is a prescription from your treating physician. Some countries have a government fund providing financial assistance for citizens to access lifesaving medical treatment abroad. You can read a detailed overview of prices and costs here. Press release, Feb 21, 2020, The Food and Drugs Administration (FDA) approval of Nexletol (bempedoic acid) for the treatment of adults with high cholesterol who are receiving guideline-recommended statin therapy was based on the data of studies CLEAR Harmony (NCT02666664) and CLEAR Wisdom (NCT02991118).1,2, CLEAR Harmony was a multi-center, randomized, double-blind trial that studied the safety of bempedoic acid in patients with hypercholesterolemia. You can pay by bank transfer or credit card. The cost for Nexletol oral tablet 180 mg is around $354 for a supply of 30 tablets, depending on the pharmacy you visit. NEXLETOL is a tablet that you take by mouth. The drug is being developed as a complementary, cost-effective, once-daily, oral cholesterol-lowering therapy. Make an enquiry and we will help you calculate the total price to buy Nexletol (bempedoic acid) online and have it delivered where you live. E sperion, the maker of bempedoic acid, said they plan to price the drug, assuming it’s cleared for market, cheaper than the PCSK9 inhibitors and are currently seeking approval for the agent as a standalone … Our Patient Support team will guide you throughout the process. To date, we have assisted patients in over 80 countries to access thousands of life-improving medicines. For the best experience on our site, be sure to turn on Javascript in your browser. In some countries we might also need an import license. 9 Similarly, the CLEAR WISDOM trial (n = 779) presented at the 2019 American College of Cardiology (ACC) meeting, … The PCSK9 inhibitors were initially priced at more than $14,000 per year, and while the cost of the alirocumab and evolocumab have been significantly reduced, they are expensive agents when compared with statins and ezetimibe, which are available as generic drugs. “I want to recommend everyone to work with this organization. With a targeted mechanism of action, bempedoic acid is a first-in-class, complementary, orally available, once-daily ATP Citrate Lyase (ACL) inhibitor that, reduces cholesterol biosynthesis and lowers LDL-C by up-regulating the LDL receptor. Please be aware that a 2.8% fee applies when paying by credit card. 6, 9, 10 In the CLEAR Harmony trial (n = 2230), bempedoic acid reduced LDL-C levels by 18% at 12 weeks. It might be possible for you to claim the cost of Nexletol (bempedoic acid) via your country's healthcare system. If you would like your order to be shipped by a specific courier, please inform us when you place the order. Nilemdo (bempedoic acid) 3 Committee discussion The appraisal committee considered evidence submitted by Daiichi Sankyo, a review of this submission by the evidence review group (ERG), the technical report, and Clinical Trial CLEAR Wisdom (NCT02991118), cited on Nov 5, 2020, 3. Make an enquiry below to learn more. Always consult your treating physician before starting a course of treatment. Crowdfunding might also be an option for you. The degree of LDL-C lowering shown by bempedoic acid in this study is consistent with prior trials. The shipping fee might also include the cost of special packaging, such as coolboxes, cool packs and data loggers, as well as transport insurance to guarantee that you receive your medicine in good order. Lowering "bad" cholesterol may help to decrease the risk of heart disease and help prevent strokes and heart attacks. Goldberg AC, JAMA, Nov 12, 2019, 5. This content has been reviewed by a Medical Doctor. You can also pick up your medicine from our partner pharmacy in Amsterdam or our partner pharmacy in Luxembourg after the order has been paid for. Should you be in doubt, please contact us by email. You'll find more details highlighted below. From your side, we’ll simply need a prescription from your treating doctor. Generally, we do not support medical insurance, but we do provide you with an invoice after you make the payment that you may send to your medical insurance company so they can reimburse you. It may be covered by your Medicare or insurance plan, but some pharmacy coupons or cash prices could help offset the cost. Bempedoic acid and ezetimibe is used together with a low-fat diet and other medicines to lower LDL cholesterol in adults with an inherited form of high cholesterol . I truly appreciate their quick, efficient and professional attitude, as well as their patience and superb customer service…”, “I highly recommend TheSocialMedwork. JavaScript seems to be disabled in your browser. Complete information about Nexletol (bempedoic acid) dosage and administration can be found in the official prescribing information listed in our references section.1. "Accessible is also important – for PCSK9 inhibitors, the challenge isn't … Bempedoic acid inhibits the synthesis of cholesterol in the liver, reducing LDL-C levels. Once we have verified your prescription and medical details, our expert sourcing team will work with our global network of suppliers to find you the best price. Data on file. – Study 1 Demonstrated Bempedoic Acid Significantly Lowered LDL-Cholesterol and Reduced hsCRP – – Over 52-Weeks, Bempedoic Acid was Observed to be Safe, Well-Tolerated, and Did Not Lead to Higher Overall Adverse Events Compared With Placebo – – Bempedoic Acid is an Oral, Once-daily ATP Citrate Lyase (ACL) Inhibitor that Reduces Cholesterol and Fatty Acid … 11 - 50. Esperion Announces Agreement with Otsuka Pharmaceutical Co., Ltd. for Development and Commercialization of NEXLETOL™ (bempedoic acid) and NEXLIZET™ (bempedoic acid and ezetimibe) Tablets in Japan Nexletol (bempedoic acid) price and additional costs The price of Nexletol (bempedoic acid) The base cost of each medicine is set by the manufacturer. Payments are fully encrypted and secure. Bempedoic acid is a prodrug and requires activation by the enzyme very-long-chain acyl-CoA synthetase 1, which is present in the liver but absent in most peripheral tissues. The shipping prices are dependent on the type of shipping necessary for the particular medicine (regular or cold chain) and upon the destination country. Select your preferred country and input your email to receive a step by step guide on how we can help you legally and safely import a medicine that is not approved in your country. Such requests are fraud schemes and are not … The maker of the drug, Esperion Therapeutics, has reported that the wholesale acquisition price of Nexletol and Nexlizet will be roughly $10 a pill, or approximately $3,650 per year. Once we have found you the lowest possible cost for your medicine, we will present you with a final offer for your approval. • The Markov model simulated the clinical outcomes and costs over a lifetime. Next we will also verify that you have a prescription from a doctor in your home country for the medicine you need. Since we help patients access medicines not available in their home country, our first step is to check that the medicine you need is not currently available in your home country. Esperion, Feb 21, 2020. In most cases we will respond to you via email, however for more complex situations, a call ensures we can process your request faster. It does so by blocking adenosine triphosphate citrate lyase, which is an enzyme in the liver that is responsible for making cholesterol. [A191877,A191913] Earlier clinical trials studying the effects of bempedoic acid showed a dose‐dependent reduction of LDL‐C levels in … Metrochem API Pvt Ltd is a Bempedoic acid API manufacturer in india.We are having technically the maximum superior manufacturing centers and our complete production procedure is as per regulatory policies.We are based on meeting our client’s needs.This helps us to produce innovative quality goods at an competitive price … Full prescribing information [FDA]: Nexletol (bempedoic acid), Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine, Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony), Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk (CLEAR Wisdom), Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol, Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease. It is a means of raising funds by using an online platform to group together many small donations from friends, family and others, in order to help you afford medical treatment. Total Quantity. When you buy Nexletol (bempedoic acid), you can make the payment by bank transfer or by credit card. They welcomed me with open arms when I went to their office in Amsterdam. Total Value. As a result, bempedoic acid lowers blood levels of cholesterol, including LDL-cholesterol and other fatty substances made by the liver.1,2, Statins lower cholesterol by blocking the activity of another cholesterol-forming enzyme, named HMG-CoA reductase. NEXLETOL (bempedoic acid) tablets, for oral use Initial U.S. Approval: 2020 -----INDICATIONS AND USAGE-----­ NEXLETOL is an adenosine triphosphate-citrate lyase (ACL) inhibitor indicated as an adjunct to diet … Evaluation of Long-Term Efficacy of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia at High Cardiovascular Risk (CLEAR Wisdom) • A Markov model was built to determine the price at which cost-effectiveness occurs. Your order will be shipped to you by our partner couriers, such as DHL, UPS and specialised cold chain couriers. Dear valued patients and customers, Full prescribing information [FDA]: Nexletol (bempedoic acid) [PDF] I was in a very difficult situation with a tight schedule, and their amazing team members…”. Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Our standard delivery time varies from 5 to 10 working days. Contact us for more details. We are registered and audited by the Dutch Ministry of Health in The Hague as an Independent Intermediary for Medicines, registration number 6730 BEM and as a Pharmaceutical Distributor with the registration number 16258 G. We support the United Nation’s 2030 Sustainable Development Goals related to Health and Equality. When paying by credit card, you can pay online once you have received your order confirmation. I want the guide for importing medicine into... By clicking "Download guide", you agree to receive emails from TheSocialMedwork (including the TheSocialMedwork newsletter and announcements). The shipping cost depends on the medicine and the destination country. AB - Background: Bempedoic acid is a novel adenosine triphosphate (ATP) citrate lyase inhibitor shown to reduce low density lipoprotein cholesterol (LDL-C) when used as an adjunct lipidlowering … They will be there to support and guide you in anyway possible to help you get the medicine you need. It works by reducing the amount of cholesterol made by the liver. • This means that a consistent room temperature of 15 to 25°C is maintained during transit. They are reliable, honest, punctual and do everything to meet your needs…”, “Dr. Bempedoic Acid. Chromatography (TLC / LC / HPLC / UPLC / GC), Complete Pharmacopoeial / Compendial Testing, Bioanalytical & Biomarker Testing Services, Bioequivalence / Clinical / Pre-Clinical Testing, Calculation and Modeling of Pharmacokinetic Parameters, Protein isolation, identification and characterization, Electrical Conductivity / High Voltage Leak Detection (HVLD), Mass Flow / Mass Extraction Leak Detection, European and Japanese Pharmacopoeia (EP & JP) Container Testing, ASTM and ISTA Distribution Simulation Testing, Environmental Conditioning, Cycling and Simulation Testing, Controlled / Immediate / Modified Release, Health / Dietary Supplement (Nutraceutical), Low Temperature / Cryogenic Condition (-78 °C), Pharmacokinetics / Pharmacodynamics / Pharmacometrics, Clinical Research Translation / Validation, Pharmacovigilance / Product Lifecycle Management, High Potent / Biologic / Controlled Substance, Customization (Anodizing, Siliconization, Plastic Coating), Media / Public Relations / Communications, Methacrylic Acid - Ethyl Acrylate Copolymer, Methacrylic Acid Methyl Methacrylate Copolymer, Polyvinyl Alcohol Graft Polyethylene Glycol Copolymer, Betadex Sulfobutyl Ether Sodium Excipient, Hydroxypropyl methylcellulose acetate succinate, Cross Linked Sodium Carboxymethylcellulose, Hepatology (Liver, Pancreatic, Gall Bladder). How and where to buy Nexletol: You can order Nexletol from TheSocialMedwork if the drug has not been approved or is not available in your country. In addition, shipping costs and a Named Patient support fee will apply. Hamstrung by payer pushback, Repatha and Praluent have been engaged in a long-running price war aimed at courting access as well as undercutting each other. The difference between bempedoic acid and placebo in mean percent change in LDL-C from baseline to Week 12 was -17% [95% CI: -21, -14].4, Please refer to the summary of product characteristics below and in the resource section for comprehensive information about the safety and effectiveness of Nexletol (bempedoic acid) for the approved indication.5, 1. Ray KK, NEJM, Mar 14, 2019, 4. We believe that it is important that they are affordable," said Mayleben. It contains 180 mg of bempedoic acid. Please note that this medicine may have also been approved in other regions than the ones we’ve listed. Please beware of fraudulent websites, communications and typo deviations used by fraudulent providers claiming to represent TheSocialMedwork. The most common side effects (≥20% of patients) listed in the prescribing information include:1, The serious adverse reactions listed in the prescribing information include:1, Nexletol (bempedoic acid) can cause fetal harm when administered to a pregnant woman, it is advised to avoid pregnancies and breastfeeding.1, For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information.1, 1. Similarly, 100 patients in both the BAþEZE FDC and bempedoic acid groups would provide 98% or greater power to detect a slightly … (kg) 5,007 kg. Esperion, Feb 21, 2020, 2. Safety and Efficacy of Bempedoic Acid to Reduce LDL Cholesterol (CLEAR Harmony) Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony) Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website … Esperion, based in Ann Arbor, Mich., announced results from its Phase III Study 2 of bempedoic acid at the American College of Cardiology (ACC) annual meeting. We are committed to the Ethical Principles of the World Medical Association. In Repatha’s Fourier cardiovascular outcomes trial, in a similar population, a placebo … Conclusions: Bempedoic acid may be cost-effective within the Australian healthcare setting at an annual acquisition price less than $600. Number of Transactions. Generally, our Named Patient support fee, shipping costs and any local tax (if applicable) are not included in the product price that is displayed on our website unless stated otherwise. The Named Patient support fee is tiered relative to the cost of the medicine. If you have a question about its approval in a specific country feel free to contact our support team. For this medication, standard shipping applies. The European Medicines Agency (EMA), Europe, on April 1, 2020, under the brand name Nilemdo for the treatment of primary hypercholesterolaemia or mixed dyslipidemia (conditions that cause high levels of fats, including cholesterol, in the blood). References: 1. Nexletol (bempedoic acid) was approved by: Nexletol is the first oral, once-daily, non-statin LDL-C lowering medicine approved since 2002 for indicated patients.3. Bempedoic acid for treating primary hypercholesterolaemia or mixed dyslipidaemia [ID1515] In development [GID-TA10534] Expected … Please be aware that due to the COVID-19 situation worldwide and the country lockdowns, we will sometimes experience delays in shipping and shortages in availability. Aysen Simsek and her team offered assistance during a very difficult time. Esperion Announces FDA Approval of NEXLETOL™ (bempedoic acid) Tablet, an Oral, Once-Daily, Non-Statin LDL-Cholesterol Lowering Medicine Click on the “Make an enquiry” button to send us any questions you have or to upload your prescription if you already have one. Esperion Therapeutics, Inc. 2019. Skip to the beginning of the images gallery, 100% success delivering to people in 85 countries, By clicking "Download guide", you agree to receive emails from TheSocialMedwork (including the TheSocialMedwork newsletter and announcements). Collected information will not be shared with any third party and complies with our stated Privacy Policy. Effect of Bempedoic Acid vs Placebo Added to Maximally Tolerated Statins on Low-Density Lipoprotein Cholesterol in Patients at High Risk for Cardiovascular Disease (CLEAR Wisdom) The price of the medicines you see on sale is the cost set by the manufacturer. We organise the sourcing, shipment and safe delivery of your medicine. The price, packaging size and strength may vary due to product availability. We are TheSocialMedwork, a registered medical intermediary that helps you access elsewhere approved medicines, no matter where you live. To date we have successfully delivered packages to over 75 countries around the world. Esperion is also awaiting an FDA decision on its bempedoic acid-ezetimibe combo, which is currently under regulatory review and scored a win in a phase 2 trial in August. The Food and Drug Administration (FDA), USA, on February 21, 2020, for the treatment of hypercholesterolemia in combination with diet and the highest tolerated statin therapy. We also highly recommend checking out local patient blogs, communities and patient organisations to find out more about your options. On Monday, Mayleben said the drug will cost patients even less than he had projected. The lowest GoodRx price for the most common version of Nexletol is around $333.12, … We support you to access approved medicine that is not approved or available in your country of residence. Cold symptoms such as stuffy nose, sneezing, sore throat. IMPORTANT NOTICE ABOUT IMPERSONATION SCAMS: Unauthorized individuals or entities are impersonating ESPERION colleagues through spoofed email, text messages and social media in an effort to gain access to bank account information and/or other personal information. In addition, bempedoic acid is specifically designed to avoid myalgias, one of the possible side effects of statin therapy. Fill out this form to enquire about Nexletol (bempedoic acid). The most common side effects include hyperuricemia (high blood levels of uric acid), pain in arms or legs, and anemia (low red blood cell counts).. Bempedoic acid blocks an … This reduces the development of atherosclerotic plaques that may increase the risk of cardiovascular events. 2. Bempedoic acid also can be used with another class of heart drugs, called PCSK9 inhibitors, which are injectable medications launched in 2015. The cost for a monthly or yearly treatment of Nexletol (bempedoic acid) depends on your prescription requirements which includes the dosage in mg and medicine type (Capsules). Bempedoic acid, sold under the brand name Nexletol among others, is a medication for the treatment of hypercholesterolemia (high blood cholesterol levels).. Submit a request for a specific medicine, or a general request, and your Patient Support Manager will contact you within 24 hours. … For lowering cholesterol, NEXLETOL is often taken with other medicines, including a group of medicines called statins. The best thing would be to check with your country's own health ministry. The base cost of each medicine is set by the manufacturer. The absence of a warning for a given medicine or combination thereof in no way should be construed to indicate that the medicine or combination is safe, effective or appropriate for any given patient. Increased levels of uric acid in your blood (hyperuricemia). Medicine information contained herein may be time sensitive. Make an enquiry for more information. Please check your spam or junk folder. Clinical Trial CLEAR Harmony (NCT02666664), cited on Nov 5, 2020, 2. Full prescribing information [FDA]: Nexletol (bempedoic acid) [PDF] Create an account with us to view and manage your quotes, import documents, prescriptions and more. After you have accepted our offer, our experienced logistics team will arrange all the shipping and transportation of your medicine. Collected information will not be shared with any third party and complies with our stated. Patients were randomized 2:1 to treatment with 180 mg bempedoic acid (n = 522) or placebo (n = 257) once daily for 52 weeks.2, The main efficacy outcome of CLEAR Harmony was safety, and the principal efficacy endpoint was the percent change from baseline in LDL cholesterol (LDL-C) level after 12 weeks.1, Overall, bempedoic acid was well tolerated in patients.3, At week 12, patients treated with bempedoic acid had a LDL-C concentration that was lowered by 19.2 mg/dl (−16.5% from baseline) [95% CI: –20.0,–16.1).3, The main efficacy outcome of CLEAR Wisdom was the percent change from baseline in LDL-C level after 12 weeks.2, Bempedoic acid was able to significantly lower LDL-C level over 12 weeks. Can I take NEXLETOL with other medicines? (USD/kg) $1,573. Our Named Patient support fee covers sourcing, logistics and following up to make sure that the order is received safely and in perfect condition. Bempedoic acid has not resulted in the profound LDL reductions seen with the PSCK9 antibodies Repatha and Praluent. Bempedoic acid is a novel adjunct lipid-lowering therapy in cardiovascular disease. Though bempedoic acid does not lower LDL-C nearly as much as the PCSK9 inhibitors, its appeal may lie in a lower expected price and oral administration. Nexletol Prices. heterozygous familial hypercholesterolemia, established atherosclerotic cardiovascular disease. • CLEAR Harmony demonstrated bempedoic acid reduces low-density lipoprotein. Similar to statins, bempedoic acid also reduces … TheSocialMedwork provides access to Nexletol (bempedoic acid) on the Named Patient import basis, which means that we work on behalf of the patient in cooperation with their treating doctor. Creating a password allows you to receive a quote and approve it or reject it in your dashboard. Following an FDA approval Friday, Esperion intends to sell bempedoic acid under the brand name Nexletol for a price of about $10 per day. Nexletol (bempedoic acid) is a member of the miscellaneous antihyperlipidemic agents drug class and is commonly used for High Cholesterol - Familial Heterozygous. The FDA approved the Esperion drug, bempedoic acid (Nexletol), late Friday. The shipping fees may include the shipping from our supplier to our partner pharmacy as well as the shipping costs to deliver the medicine to the patient’s country of residence. The trade data from India has not been released since November 2016, as an official government notification, dated 25.11.2016, rescinded publication of daily import and export trade data.
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