New Novo Nordisk initiatives support patient access to authentic, FDA-approved Wegovy® as federal ban on mass compounding of "semaglutide" takes effect

With all doses of FDA-approved Wegovy® fully available nationwide, it is illegal under US compounding laws to make or sell knockoff "semaglutide" drugs, with rare exceptions New, one-time $199 first-month offer for Wegovy® available through June 30, 2025; offer designed to help new self-paying patients previously prescribed unapproved "semaglutide" start on FDA-approved Wegovy® "Choose the Real Thing" campaign launching to raise awareness about the dangers of knockoff "semaglutide" Novo Nordisk intensifies legal actions aimed at protecting patients from risks and dangers associated with compounded "semaglutide" drugs and their foreign illicit active ingredients , /PRNewswire/ -- Today, as the US Food and Drug Administration (FDA) grace period for mass compounding of "semaglutide" expires, Novo Nordisk announced a series of initiatives to further support patient access to authentic, FDA-approved Wegovy® (semaglutide) injection 2.4 mg. As the company's efforts to safeguard patients from the dangers of illicit and illegal compounded "semaglutide" continues, a one-time offer for self-paying patients new to Wegovy® is now available for a limited time, through June 30, 2025. "Mass compounding of 'semaglutide' is illegal, dangerous, and must stop now, which is why we are doubling down on our commitment to accessibility, availability, and affordability of authentic, FDA-approved Wegovy®," said Dave Moore, Executive Vice President, U.S. Operations of Novo Nordisk Inc. "Novo Nordisk always puts patient safety first, and we urge all stakeholders, including the FDA, Boards of Pharmacy, and law enforcement, to take decisive action to uphold the highest quality standards of care." This one-time offer is intended to help patients who have previously been prescribed unapproved or illicit "semaglutide" drugs and are seeking access to authentic, FDA-approved Wegovy®. Novo Nordisk is offering self-paying patients who are new to Wegovy® their first month of medicine for $199 through June 30, 2025. For subsequent months, self-pay patients will pay $499 per month. Patients can access this offer in multiple ways: If prescribed Wegovy® by their local healthcare professional, they can activate their one-time offer at Wegovy.com, then either print or have it sent straight to their phone prior to visiting their pharmacy of choice. These savings will also be available through telehealth providers integrated with NovoCare® Pharmacy, allowing them to pass the savings along to their customers in line with their offerings and services. The savings offer is also available through NovoCare® Pharmacy. CenterWell Pharmacy is the dispensing pharmacy managing prescription fulfilment and delivery for NovoCare® Pharmacy. At Wegovy.com, patients can check to see if their commercial insurance provider covers Wegovy®, which could lead to paying as little as $0/month. Full terms and conditions for all offers are available at WegovyTerms.com.The company continues to invest in actively correcting misinformation and educating communities about the risks of knockoff "semaglutide" – including a new advertising campaign informing the public on the dangers of knockoffs and inviting them to "Choose the Real Thing." This new campaign builds on the success of the "Check Before You Inject" advertisement and will launch in digital channels at the end of May. The campaign emphasizes the importance of using FDA-approved treatments and directs patients to trusted resources like semaglutide.com, where they can learn more about identifying legitimate products and avoiding compounded or counterfeit drugs.Now that the FDA's grace period has ended, any entity that mass produces or sells knockoff "semaglutide" is breaking the law and putting patient safety at risk. Attempts by compounders to evade these laws by making manipulated, unnecessary, and pretextual changes to ingredients, routes of administration, or dosages are also unlawful.Nearly all "semaglutide" used in compounding is manufactured by Chinese and other foreign suppliers. The FDA has never authorized or approved the manufacturing processes used by any of these foreign suppliers, nor has the FDA reviewed or authorized the quality of the "semaglutide" they produce. A recently published report by the Brookings Institute found that these foreign suppliers are making up their own standards for manufacturing "semaglutide," and Novo Nordisk's testing has revealed that the "semaglutide" used in compounding is manufactured using a process that poses significant safety risks to patients.According to analysis by Novo Nordisk, more than half of the Chinese suppliers that shipped "semaglutide" into the US for compounding or further manufacturing in 2024 – and so far in 2025 – are not even permitted to manufacture "semaglutide" for use in drugs in China. However, they are exporting this "semaglutide" into the US for use by compounding pharmacies for US patients.To date, Novo Nordisk has filed nearly 120 lawsuits across 34 states against compounders and other entities making false and misleading claims about "semaglutide" drugs, including entities deceiving patients into believing they are receiving "personalized" or "customized" drugs. Novo Nordisk will continue pursuing legal action to protect patients from the risks posed by unapproved knockoff drugs and foreign illicit active pharmaceutical ingredients (API).About obesityObesity is a serious chronic, progressive, and misunderstood disease that requires long-term management.1-3 One key misunderstanding is that this is a disease of just lack of willpower, when in fact there is underlying biology that may impede people with obesity from losing weight and keeping it off.1,3 Obesity is influenced by a variety of factors, including genetics, social determinants of health, and the environment.4,5The prevalence of overweight and obesity is a public health issue that has severe cost implications to healthcare systems.6,7 In the U.S., about 40% of adults live with obesity.8About Wegovy® (semaglutide) injection 2.4 mg What is Wegovy®? WEGOVY® (semaglutide) injection 2.4 mg is an injectable prescription medicine used with a reduced calorie diet and increased physical activity: to reduce the risk of major cardiovascular events such as death, heart attack, or stroke in adults with known heart disease and with either obesity or overweight. that may help adults and children aged 12 years and older with obesity, or some adults with overweight who also have weight-related medical problems, to help them lose excess body weight and keep the weight off. Wegovy® contains semaglutide and should not be used with other semaglutide-containing products or other GLP-1 receptor agonist medicines.It is not known if Wegovy® is safe and effective for use in children under 12 years of age.Important Safety Information What is the most important information I should know about Wegovy®? Wegovy® may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your healthcare provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Wegovy® and medicines that work like Wegovy® caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people Do not use Wegovy® if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) Do not use Wegovy® if: you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2) you have had a serious allergic reaction to semaglutide or any of the ingredients in Wegovy® Before using Wegovy®, tell your healthcare provider if you have any other medical conditions, including if you: have or have had problems with your pancreas or kidneys have type 2 diabetes and a history of diabetic retinopathy have or have had depression, suicidal thoughts, or mental health issues are scheduled to have surgery or other procedures that use anesthesia or deep sleepiness (deep sedation) are pregnant or plan to become pregnant. Wegovy® may harm your unborn baby. You should stop using Wegovy® 2 months before you plan to become pregnant are breastfeeding or plan to breastfeed. It is not known if Wegovy® passes into your breast milk Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Wegovy® may affect the way some medicines work and some medicines may affect the way Wegovy® works. Tell your healthcare provider if you are taking other medicines to treat diabetes, including sulfonylureas or insulin. Wegovy® slows stomach emptying and can affect medicines that need to pass through the stomach quickly.What are the possible side effects of Wegovy®? Wegovy® may cause serious side effects, including: inflammation of your pancreas (pancreatitis). Stop using Wegovy® and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back gallbladder problems. Wegovy® may cause gallbladder problems, including gallstones. Some gallstones may need surgery. Call your healthcare provider if you have symptoms, such as pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools increased risk of low blood sugar (hypoglycemia), especially those who also take medicines for diabetes such as insulin or sulfonylureas. This can be a serious side effect. Talk to your healthcare provider about how to recognize and treat low blood sugar and check your blood sugar before you start and while you take Wegovy®. Signs and symptoms of low blood sugar may include dizziness or light-headedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, or feeling jittery kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Wegovy®. Tell your healthcare provider if you have stomach problems that are severe or will not go away. serious allergic reactions. Stop using Wegovy® and get medical help right away, if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat change in vision in people with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Wegovy® increased heart rate. Wegovy® can increase your heart rate while you are at rest. Tell your healthcare provider if you feel your heart racing or pounding in your chest and it lasts for several minutes depression or thoughts of suicide. You should pay attention to any mental changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you food or liquid getting into the lungs during surgery or other procedures that use anesthesia or deep sleepiness (deep sedation). Wegovy® may increase the chance of food getting into your lungs during surgery or other procedures. Tell all your healthcare providers that you are taking Wegovy® before you are scheduled to have surgery or other procedures The most common side effects of Wegovy® may include: nausea, diarrhea, vomiting, constipation, stomach (abdomen) pain, headache, tiredness (fatigue), upset stomach, dizziness, feeling bloated, belching, low blood sugar in people with type 2 diabetes, gas, stomach flu, heartburn, and runny nose or sore throat.Please see Medication Guide and Prescribing Information, including Boxed Warning, for Wegovy® at https://www.novo-pi.com/wegovy.pdfAbout the Wegovy® savings offer The Wegovy® savings offer gives cash-paying patients or those with commercial insurance that does not cover obesity medicines access to a 28-day supply (one box) of Wegovy® for $499. Patients enrolled in government-funded healthcare programs are not eligible for these savings offers. Patients with commercial insurance that does cover Wegovy® may pay as little as $0 per month with a maximum savings of $225 for a 28-day supply of Wegovy®. Novo Nordisk is offering self-paying patients who are new to Wegovy® their first month of medicine for $199 through June 30, 2025. For subsequent months, self-pay patients will pay $499 per month.About NovoCare® Pharmacy NovoCare® Pharmacy provides cash-paying patients who have been prescribed Wegovy® with the ability to schedule shipments of their Wegovy® prescriptions directly to their home. Beyond convenient home delivery, NovoCare® also supports patients with benefit verification, refill reminders, and access to live support from a NovoCare® case manager. More information about NovoCare® Pharmacy is available at NovoCare.com. Novo Nordisk is continuing to take multiple proactive measures to keep patients safe. More information can be found on semaglutide.com. About CenterWell CenterWell is a leading health care services business focused on creating integrated and differentiated experiences that put our patients at the center of everything we do. The result is high quality health care that is accessible, comprehensive, and, most of all, personalized. CenterWell is the largest provider of senior-focused primary care, one of the leading providers of home health care, and a leading integrated home delivery, specialty, hospice, and retail pharmacy. CenterWell Pharmacy's home delivery pharmacy services are designed to provide safe, convenient, and affordable access to medications, while supporting adherence to treatment plans.CenterWell is part of Humana Inc. Learn more about what we offer at CenterWell.com.About Novo NordiskNovo Nordisk is a leading global healthcare company that's been making innovative medicines to help people with diabetes lead longer, healthier lives for more than 100 years. This heritage has given us experience and capabilities that also enable us to drive change to help people defeat other serious chronic diseases such as obesity, rare blood, and endocrine disorders. We remain steadfast in our conviction that the formula for lasting success is to stay focused, think long-term, and do business in a financially, socially, and environmentally responsible way. With a US presence spanning 40 years, Novo Nordisk US is headquartered in New Jersey and employs over 10,000 people throughout the country across 12 manufacturing, R&D and corporate locations in eight states plus Washington DC. For more information, visit novonordisk-us.com, Facebook, Instagram, and X.Novo Nordisk is committed to the responsible use of our semaglutide-containing medicines which represent distinct products with different indications, dosages, prescribing information, titration schedules, and delivery forms. These products are not interchangeable and should not be used outside of their approved indications. Learn more at semaglutide.com.Contacts for further informationReferences: Kaplan LM, Golden A, Jinnett K, et al. Perceptions of barriers to effective obesity care: results from the national action study. Obesity. 2018;26(1):61-69. Bray GA, Kim KK, Wilding JPH; World Obesity Federation. Obesity: a chronic relapsing progressive disease process. A position statement of the World Obesity Federation. Rev. 2017;18(7):715-723. Garvey WT, Mechanick JI, Brett EM, et al. American association of clinical endocrinologists and American College of Endocrinology comprehensive clinical practice guidelines for medical care of patients with obesity. Endocr Pract. 2016;22 (Suppl 3):1-203. Centers for Disease Control and Prevention. Adult obesity facts. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/adult-obesity-facts/index.html. Centers for Disease Control and Prevention. Risk Factors for Obesity. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/risk-factors/risk-factors.html. World Obesity Federation. World Obesity Atlas 2023. Last accessed: May 2025. Available at: https://www.worldobesity.org/resources/resource-library/world-obesity-atlas-2023. Centers for Disease Control and Prevention. Why it matters. Last accessed: May 2025. Available at: https://www.cdc.gov/obesity/php/about/?CDC_AAref_Val=https://www.cdc.gov/obesity/about-obesity/why-it-matters.html. Centers for Disease Control and Prevention. Obesity and Severe Obesity Prevalence in Adults: United States, August 2021–August 2023. Last accessed May 2025. Available at: https://www.cdc.gov/nchs/products/databriefs/db508.htm. SOURCE NOVO NORDISK INC. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In

New Novo Nordisk initiatives support patient access to authentic, FDA-approved Wegovy® as federal ban on mass compounding of "semaglutide" takes effect

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