Dyslipidemias

CENTER VALLEY, Pa., March 19, 2024 /PRNewswire/ -- Olympus, a leading global medtech company providing innovative solutions for medical and surgical procedures, announced today it applauds the new Obesity Bill of Rights . Continue Reading Olympus applauds the newly launched Obesity Bill of Rights and will support the initiative by working to build awareness and talking to its healthcare customers about this important campaign to counter bias and ageism in obesity care. Olympus will support the initiative by working to build awareness and talking to its healthcare customers about this important campaign to counter bias and ageism in obesity care. The program, spearheaded in January 2024 in the U.S. by the National Consumers League (NCL), a nonprofit consumer advocacy group, in conjunction with the National Council on Aging (NCOA), establishes a set of rights to "assure screening, diagnosis, counseling and effective treatment based on medical treatment guidelines." This ongoing effort to gather support is expected to culminate in a fully implemented Bill of Rights by Dec. 31, 2029. The NCL and NCOA are working at the grassroots, employer, state and federal levels on this effort to ensure equal access to care for all obesity patients. NCL and NCOA worked with health leaders and obesity specialists to draft these Bill of Rights tenets that are intended to change the narrative, such that the healthcare industry more effectively sees obesity as a treatable chronic disease that can be treated with the same "respect, attention and medical care" as other chronic conditions. Statistics regarding obesity are staggering: 108M people in the U.S. are considered obese, only 10% of whom get help from medical professionals and only 2% of whom are treated with new medications. More than 230 conditions are worsened by obesity. Obesity is connected to $1.73 trillion in annual medical costs in the U.S. 400K premature deaths annually are linked to obesity.1 "Olympus provides equipment to the surgical community that helps in the treatment of obesity, and statistics show that not enough people have access to this type of treatment," said Paul Skodny, Executive Director for Health Economics and Market Access at Olympus Corporation. "It is our hope that awareness of treatment options and equitable access and insurance coverage will help address the detrimental health impacts of obesity." Bariatric Surgery as a Solution for Weight Loss Because of recent pharmaceuticals' entry into the market, such as semaglutide-based medications, obesity treatment has been receiving more attention. Surgical treatment which can complement medical management, has a lengthy track record, having been available to patients for decades with favorable long-term outcomes.2 Studies show patients typically lose the most weight one to two years after bariatric surgery and see substantial improvements in obesity-related conditions. Despite the growing number of obesity-related health problems, fewer than 2% of those eligible for bariatric surgery elect to have it.3 Given these statistics, Olympus, maker of technologies for performing minimally invasive bariatric procedures, sought to understand the awareness level and concerns of eligible patients in a survey conducted in 20194: Marginal Awareness around Benefits: A little more than 50% of respondents demonstrated only marginal awareness that bariatric surgery causes hormonal changes that improve weight loss by maintaining or enhancing energy expenditure.5 Worry about Gaining Weight Back: 20% of respondents were avoiding bariatric surgery because of concerns about surgery complications and gaining the weight back. Awareness around Insurance Opportunities: 56% of respondents were aware that insurance covers bariatric surgery in most qualified cases.6 Surgical benefits are real and should be known to more patients. Studies show that: Patients may lose as much as 60% of excess weight six months after surgery, and 77% of excess weight as early as 12 months after surgery. On average, five years after surgery, patients maintain 50% of their excess weight loss.1 The majority of bariatric surgery patients with diabetes, dyslipidemia, hypertension, and obstructive sleep apnea experience remission of these obesity-related diseases.1 Statistically, the risk of death during weight-loss surgery procedures is less than 1 percent. All abdominal operations carry the risks of bleeding, infection in the incision, thrombophlebitis of legs (blood clots), lung problems (pneumonia, pulmonary embolisms), strokes or heart attacks, anesthetic complications and blockage or obstruction of the intestine. These risks are greater in patients with severe obesity.7 To learn more about Olympus' state-of-the-art technologies for performing minimally invasive bariatric surgeries, visit the Bariatrics product page. About Olympus At Olympus, we are committed to our purpose of making people's lives healthier, safer and more fulfilling. As a global medical technology company, we partner with healthcare professionals striving to provide best-in-class solutions and services for early detection, diagnosis and minimally invasive treatment, aiming to improve patient outcomes by elevating the standard of care in targeted disease states. For more than 100 years, Olympus has pursued a goal of contributing to society by producing products designed with the purpose of delivering optimal outcomes for its customers around the world. For more information, visit medical.olympusamerica.com. _______________________________ 1 Americans now have an Obesity Bill of Rights. NCLnet.org. . Published January 31, 2024. Accessed February 29, 2024. 2 Story of Obesity Surgery. asmbs.org. . Published 2023. Accessed February 29, 2024. 3 . February 27, 2020. Accessed February 29, 2024. 4 The Olympus-commissioned online survey was conducted mid-December 2019. 5 Public Education Committee. Benefits of Bariatric Surgery: ASMBS. American Society for Metabolic and Bariatric Surgery. . Accessed February 29, 2024. 6 Manning S. How to get your health insurer to pay for your weight-loss surgery. Insure.com. . Published September 24, 2020. Accessed February 29, 2024. 7 Available Procedures. Yale New Haven Health. . Accessed March 15, 2024. SOURCE Olympus Corporation of the Americas

- Application based on integrated global data dossier completed for Lerodalcibep by LIB - Hasten to begin bridging studies to support planned BLA submission in China CINCINNATI--(BUSINESS WIRE)-- LIB Therapeutics, Inc. (LIB), a privately-held, late-stage biopharmaceutical company advancing Lerodalcibep, a potential best in class PCSK9 inhibitor for the treatment and prevention of cardiovascular disease (CVD), today announced that its regional partner in China, Hasten Biopharmaceuticals Co, Ltd. (Hasten), has received notification of acceptance for the clinical trial application for Lerodalcibep by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. In September 2023, LIB announced that it had entered into an agreement granting Hasten the rights to develop and commercialize Lerodalcibep in Greater China (Chinese Mainland, Hong Kong, Macau and Taiwan) and will be responsible for clinical development and regulatory approval in these territories. The acceptance of the Lerodalcibep clinical trial application by the NMPA was based on the integrated data dossier provided by LIB, including CMC, non-clinical and clinical studies completed in the U.S., Europe, and rest of world as well as the clinical development plan in China proposed by Hasten. “We are excited for Hasten to begin the bridging studies necessary to seek approval and to bring Lerodalcibep to a large and growing population in China with CVD who need substantial additional LDL-C reductions, despite being on statin therapy,” said David Cory, Chief Executive Officer of LIB. “We are preparing our own Lerodalcibep BLA submission to the FDA, to be followed by MAA submission to EMA. Lerodalcibep has a potential best in class LDL-C lowering pro will be differentiated as a more patient-friendly, once-monthly, small-volume, single subcutaneous injection that will not require refrigeration at home or in travel.” About Lerodalcibep Lerodalcibep is a potential best in class, novel, small binding protein, third-generation PCSK9 inhibitor, and has been developed as a more convenient, once-monthly dose in a small injection volume and with long-ambient stability. Combined with sustained LDL-C reductions demonstrated in clinical trials, Lerodalcibep is expected to expand treatment options for the millions of patients around the world with atherosclerotic cardiovascular disease (ASCVD), and those at very high and high risk for ASCVD, including the 30 million individuals with more severe inherited high-cholesterol called familial hypercholesterolemia (FH). The global Phase 3 LIBerate program with over 2,700 patients enrolled a diverse population of patients with CVD, without CVD at very high and high risk for CVD, including heterozygous and homozygous familial hypercholesterolemia (FH). Key registration placebo-controlled trials included Lerodalcibep once-monthly for up to 52 weeks, and over 2,400 patients continued in the 72-week open-label extension trial. LIB is preparing a biologics license application (BLA) for submission to the Food and Drug Administration followed by a marketing authorization application (MAA) for submission to the European Medicines Agency. About Hasten Biopharmaceutical Company, Ltd. Hasten Biopharmaceutical Co., Ltd., which integrates R&D, production and commercial promotion and covers the whole industrial chain, was established in 2020. Hasten is committed to becoming a leader in the healthcare industry. Through joining hands with the stakeholders such as relevant government institutions, medical and health professionals and industry partners, Hasten provides high-quality medicines and solutions to benefit patients and create social value. About LIB Therapeutics, Inc. LIB Therapeutics is a privately-held, late-stage biopharmaceutical company dedicated to bringing novel, safe and convenient subcutaneous and oral PCSK9 inhibitors to the millions of patients with cardiovascular disease and the 30 million individuals with familial hypercholesterolemia (FH), who require additional large reductions in low density lipoprotein-cholesterol (LDL-C) despite maximally tolerated statins and other lipid lowering agents. For more information, please visit: .

Rezdiffra becomes the first and only medication approved by the FDA for the treatment of NASH (also known as “MASH”) Accelerated approval was based on Phase 3 data demonstrating that Rezdiffra improved liver fibrosis and resolved NASH in patients with noncirrhotic NASH with moderate to advanced liver fibrosis Rezdiffra prescribing information does not include a liver biopsy requirement for diagnosis Madrigal conference call scheduled for March 14, 2024, at 5:15 pm ET March 14, 2024 -- Madrigal Pharmaceuticals, Inc. (NASDAQ:MDGL), a biopharmaceutical company focused on delivering novel therapeutics for nonalcoholic steatohepatitis (NASH), today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Rezdiffra (resmetirom) in conjunction with diet and exercise for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials. Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy. The accelerated approval of Rezdiffra is a culmination of more than 15 years of research from our founder Dr. Becky Taub and a small R&D team that took on one of the biggest challenges in drug development. This is a historic moment for the NASH field and represents the best of what our industry is capable of. We’re excited to deliver Rezdiffra to patients in need.” Becky Taub, M.D., the Founder, Chief Medical Officer and President of Research & Development of Madrigal, stated, “Madrigal would like to thank the many patients who made the accelerated approval of Rezdiffra possible by participating in our clinical studies. We believe Rezdiffra will change the treatment paradigm for NASH with moderate to advanced liver fibrosis, giving physicians a liver-directed therapy to help improve fibrosis and resolve NASH before their patients progress to cirrhosis.” Wayne Eskridge, Co-Founder and Chief Executive Officer of the Fatty Liver Foundation, stated, “This is a day of celebration for patients with NASH who have been waiting many years for the first approved therapy. I believe this approval milestone will bring new energy and momentum to the NASH community, accelerating our efforts to improve disease education, build care pathways, and expand investment in NASH research.” Rezdiffra is a once-daily, oral THR-β agonist designed to target key underlying causes of NASH. The accelerated approval of Rezdiffra was based on results from the Phase 3 MAESTRO-NASH trial, which was recently published in the New England Journal of Medicine. MAESTRO-NASH is an ongoing pivotal, multicenter, randomized, double-blind, placebo-controlled trial that enrolled 1,759 patients with biopsy-confirmed NASH. Following 52 weeks of treatment, both 100 mg and 80 mg doses of Rezdiffra demonstrated statistically significant improvement compared to placebo on two primary endpoints: NASH resolution (including a reduction in the nonalcoholic fatty liver disease [NAFLD] activity score by ≥2 points) with no worsening of fibrosis, and an improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score. Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage. The Rezdiffra prescribing information does not include a liver biopsy requirement for diagnosis. The recommended dosage of Rezdiffra is based on actual body weight. For patients weighing Stephen Harrison, M.D., Chairman for both Pinnacle Clinical Research and Summit Clinical Research, San Antonio, Texas, Visiting Professor of Hepatology, Oxford University, and lead Principal Investigator of the MAESTRO studies, commented, “The approval of the first medication for NASH is a true game-changer for healthcare providers, the research community and, most importantly, patients living with this serious liver condition. Based on the robust efficacy and safety data generated in two large Phase 3 MAESTRO studies, I believe Rezdiffra will become the foundational therapy for patients with NASH with moderate to advanced liver fibrosis.” Dr. Harrison continued, “Importantly, we continue to study Rezdiffra to determine if the positive results observed in the MAESTRO studies will lead to reduced risk of progression to cirrhosis, liver failure, need for liver transplant and premature mortality.” MAESTRO-NASH remains ongoing as an outcomes study designed to generate confirmatory data that, if positive, will help verify clinical benefit and may support full approval. A second ongoing outcomes trial is evaluating progression to liver decompensation events in patients with well-compensated NASH cirrhosis treated with Rezdiffra versus placebo. Rezdiffra should not be used in patients with decompensated cirrhosis. The most common adverse reactions reported in patients treated with Rezdiffra included diarrhea, nausea, pruritis, abdominal pain, vomiting, constipation, and dizziness. Diarrhea and nausea typically began early in treatment initiation and were mild to moderate in severity. A separate, noninvasive Phase 3 trial, MAESTRO-NAFLD-1, evaluated the safety and tolerability of Rezdiffra and contributed to the safety database supporting regulatory benefit-risk assessment. Rezdiffra is expected to be available to patients in the U.S. in April and will be distributed through a limited specialty pharmacy network. Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program. This program is designed to help patients navigate insurance and affordability challenges and provide co-pay support for eligible patients. Madrigal has also established a patient assistance program (PAP) to help patients with no insurance access Rezdiffra. Madrigal will host a conference call and webcast today at 5:15 PM ET to discuss the accelerated approval of Rezdiffra. To access the webcast of the call with slides please visit the Investors section of Madrigal’s website or click here. An archived webcast will be available on the Madrigal website after the event. MAESTRO-NASH is an ongoing Phase 3 trial that enrolled 1759 patients with biopsy-confirmed NASH. Patients were randomly assigned in a 1:1:1 ratio to receive once-daily Rezdiffra at a dose of 80 mg or 100 mg or placebo. The two primary endpoints at week 52 were NASH resolution with no worsening of fibrosis and an improvement in fibrosis by at least one stage with no worsening of the NAFLD activity score. The key secondary endpoint was the percent change from baseline in LDL cholesterol at week 24. Rezdiffra achieved both primary endpoints and the key secondary endpoint of the MAESTRO-NASH trial. Additionally, Rezdiffra improved liver enzymes, fibrosis biomarkers and imaging tests as compared with placebo. The primary results of the trial were published in the New England Journal of Medicine in February 2024. Patients enrolled in the MAESTRO-NASH trial continue on therapy after the initial 52-week treatment period for up to 54 months to accrue and measure hepatic clinical outcome events including progression to cirrhosis on biopsy and hepatic decompensation events, as well as all-cause mortality. The 54-month outcomes portion of the trial is designed to generate confirmatory data that, if positive, will help verify Rezdiffra’s clinical benefit and may support full approval. Nonalcoholic steatohepatitis (NASH) is a more advanced form of nonalcoholic fatty liver disease (NAFLD). NASH is a leading cause of liver-related mortality and an increasing burden on healthcare systems globally. Additionally, patients with NASH, especially those with more advanced metabolic risk factors (hypertension, concomitant type 2 diabetes), are at increased risk for adverse cardiovascular events and increased morbidity and mortality. Once patients progress to NASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), the risk of adverse liver outcomes increases dramatically. NASH is rapidly becoming the leading cause of liver transplantation in the U.S. Madrigal estimates that approximately 1.5 million patients have been diagnosed with NASH in the U.S., of which approximately 525,000 have NASH with moderate to advanced liver fibrosis. Madrigal plans to focus on approximately 315,000 diagnosed patients with NASH with moderate to advanced liver fibrosis under the care of the liver specialist physicians during the launch of Rezdiffra. NASH is also known as metabolic dysfunction associated steatohepatitis (MASH). In 2023, global liver disease medical societies and patient groups came together to rename the disease, with the goal of establishing an affirmative, non-stigmatizing name and diagnosis. Nonalcoholic fatty liver disease (NAFLD) was renamed metabolic dysfunction-associated steatotic liver disease (MASLD), NASH was renamed MASH, and an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. In addition to liver disease, patients with MASH have at least one related comorbid condition (e.g., obesity, hypertension, dyslipidemia, or type 2 diabetes). What is Rezdiffra? Rezdiffra is a prescribed medicine used along with diet and exercise to treat adults with nonalcoholic steatohepatitis (NASH) with moderate to advanced liver scarring (fibrosis), but not with cirrhosis of the liver. It is not known if Rezdiffra is safe and effective in children (under 18 years old). This indication is approved based on improvement of NASH and liver scarring (fibrosis). There are ongoing studies to confirm the clinical benefit of Rezdiffra. Before you take Rezdiffra, tell your healthcare provider about all of your medical conditions, including if you: have any liver problems other than NASH. have gallbladder problems or have been told you have gallbladder problems, including gallstones. are pregnant or plan to become pregnant. It is not known if Rezdiffra will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Rezdiffra passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby if you take Rezdiffra. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Rezdiffra and other medicines may affect each other, causing side effects. Rezdiffra may affect the way other medicines work, and other medicines may affect how Rezdiffra works. Especially tell your healthcare provider if you take medicines that contain gemfibrozil to help lower your triglycerides, or cyclosporine to suppress your immune system, because Rezdiffra is not recommended in patients taking these medicines. Tell your healthcare provider if you are taking medicines such as clopidogrel to thin your blood or statin medicines to help lower your cholesterol. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. What are the possible side effects of Rezdiffra? Rezdiffra may cause serious side effects, including: liver injury (hepatotoxicity). Stop taking Rezdiffra and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: tiredness, nausea, vomiting, fever, rash, your skin or the white part of your eyes turns yellow (jaundice), pain or tenderness in the upper middle or upper right area of your stomach (abdomen). gallbladder problems. Gallbladder problems such as gallstones, inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with NASH and may occur if you take Rezdiffra. Call your healthcare provider right away if you develop any signs or symptoms of these conditions including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting. The most common side effects of Rezdiffra include: diarrhea, nausea, itching, stomach (abdominal) pain, vomiting, dizziness, constipation. These are not all the possible side effects of Rezdiffra. For more information, ask your healthcare provider or pharmacist. Madrigal Pharmaceuticals, Inc. (Nasdaq: MDGL) is a biopharmaceutical company pursuing novel therapeutics for nonalcoholic steatohepatitis (NASH), a liver disease with high unmet medical need. Madrigal’s medication, Rezdiffra (resmetirom), is a once-daily, oral, liver-directed THR-β agonist designed to target key underlying causes of NASH. For more information, visit www.madrigalpharma.com. The content above comes from the network. if any infringement, please contact us to modify.