Novo Nordisk ends deal with Hims & Hers over sales of Wegovy copycats; HIMS drops 34%
Novo Nordisk said it is ending its collaboration with Hims & Hers due to concerns about the telehealth company's sales and promotion of cheaper knock-offs of the weight loss drug Wegovy.
Novo Nordisk in April said it would offer Wegovy through several telehealth companies, such as Hims & Hers, to expand access to the blockbuster injection now that it is no longer in short supply in the U.S.
But Novo Nordisk said Hims & Hers has "failed to adhere to the law which prohibits mass sales of compounded drugs" and accused the telehealth company of "deceptive" marketing that is putting patient safety at risk.
The "Wegovy" brand slimming syringe is sold in the Achat pharmacy in Mitte. The "Wegovy" slimming syringe has been available in Germany for a year.
Jens Kalaene | Picture Alliance | Getty Images
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Yahoo
13 minutes ago
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European regulatory authority adopts positive opinion for Novo Nordisk's Alhemo® (concizumab), recommending label expansion to treat haemophilia A and B without inhibitors
Pending European Commission (EC) approval, Alhemo® will become available to all adult and paediatric patients 12 years and older living with severe haemophilia A and moderate or severe haemophilia B without inhibitors. This positive opinion by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) is based on results from the explorer8 trial, which showed that Alhemo® reduced spontaneous and traumatic bleeds for patients living with haemophilia A and B without inhibitors compared with no prophylaxis1. If approved by the EC, Alhemo®, with its pen-injector device, has the potential to be an efficacious and easy-to-use option for patients with haemophilia A and B without inhibitors1-3. Bagsværd, Denmark, 25 July 2025 – Novo Nordisk today announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending an update of the Alhemo® (concizumab) label to include the treatment of severe haemophilia A and moderate or severe haemophilia B without inhibitors. 'If approved by the European Commission, this label update would extend Alhemo®'s convenient once-daily, under-the-skin administration to patients living with haemophilia without inhibitors, providing an efficacious prophylactic choice,' said Martin Holst Lange, executive vice president and head of Development at Novo Nordisk. 'Each person living with haemophilia has individual and evolving needs. With its user-friendly, pre-filled, portable pen, we believe that Alhemo® has the potential to offer even more patients an individualised and flexible treatment.' The positive CHMP opinion is based on the results from the phase 3 explorer8 trial, which met its primary endpoint. The results demonstrated that Alhemo® prophylaxis compared with no prophylaxis treatment led to an 86% reduction and 79% reduction in treated spontaneous and traumatic bleeds for patients living with haemophilia A without inhibitors and haemophilia B without inhibitors1, respectively. In this trial, Alhemo® showed a favourable safety profile in patients with haemophilia A and B without inhibitors1. Patient-Reported Outcome (PRO) data from the explorer8 study further indicated an improvement in health-related quality of life and reduction in treatment burden with Alhemo® treatment compared with no prophylaxis3. Specifically, trends favouring Alhemo® over prophylaxis were observed in the short-form health survey (SF-36v2) and Haemophilia Quality of Life Questionnaire for Adults (Haem-A-QoL) results, in patients with haemophilia A and haemophilia B; these included the change in 'bodily pain' and 'physical functioning' from baseline to week 24 in the survey, and the Haem-A-QoL 'total score' and the 'physical health' domain score3. Treatment preference results showed patients were also in favour of Alhemo® over no prophylaxis or previous treatment, with 70.9% of respondents indicating they prefer Alhemo® over their previous haemophilia treatment3. Following the positive opinion from the CHMP, Novo Nordisk expects the European Commission (EC) to approve the label update within approximately two months. About Alhemo® (concizumab)Alhemo® (concizumab) is an anti-tissue factor pathway inhibitor (TFPI), monoclonal antibody designed to block a protein in the body that stops blood from clotting. By blocking TFPI, Alhemo® ensures the production of thrombin, which helps to clot the blood and prevent bleeding4. Alhemo® is currently approved in Europe5, the United States6, India7, Brazil8 and Switzerland9 for the treatment of adolescents and adults (12 years or older) with haemophilia A and B with inhibitors. In Japan10 and Australia11, Alhemo® is currently approved for the treatment of adolescents and adults (12 years or older) with haemophilia A and B with and without inhibitors. In all approved countries, it is indicated for routine prophylaxis to prevent or reduce the frequency of bleeding episodes. About the explorer8 studyExplorer8 is a multicentre, open-label, randomised, phase 3a clinical trial aimed to establish the efficacy and safety profile of Alhemo® in adults and paediatric patients 12 years of age and older living with congenital severe haemophilia A or moderate or severe haemophilia B without inhibitors1,12. In explorer8, 148 patients were randomly assigned in a 1:2 ratio to receive no prophylaxis (arm 1, n=21) or Alhemo® prophylaxis (arm 2, n=42), and 85 were nonrandomly assigned to receive Alhemo® prophylaxis (arms 3 and 4). The initial loading dose of Alhemo® was 1 mg per kilogram of body weight, followed by 0.2 mg per kilogram daily, and potentially individualised on the basis of concizumab plasma concentration as measured at Week 41,12. The primary analysis was carried out when all patients in arms 1 and 2 completed at least 24 or 32 weeks, respectively, and compared the number of treated spontaneous and traumatic bleeding episodes, measured as annualised bleeding rate, between arms 1 and 21,12. Supportive secondary endpoints, such as percent of patients experiencing zero bleeds, are reported as descriptive results only1,12. The trial is still ongoing in the extension phase and is expected to complete in 20281,12. About haemophiliaHaemophilia is a rare inherited bleeding disorder that impairs the body's ability to make blood clots, a process needed to stop bleeding. It is estimated to affect approximately 1,125,000 people worldwide13. Due to the nature of haemophilia being an x-linked recessive disorder, it often presents differently in males compared with females, with roughly 88% of people diagnosed with haemophilia worldwide being male14,15. There are different types of haemophilia, which are characterised by the type of clotting factor protein that is defective or missing. Haemophilia A is caused by a missing or defective clotting Factor VIII (FVIII), and haemophilia B is caused by a missing or defective clotting Factor IX (FIX). About Novo NordiskNovo Nordisk is a leading global healthcare company founded in 1923 and headquartered in Denmark. Our purpose is to drive change to defeat serious chronic diseases built upon our heritage in diabetes. We do so by pioneering scientific breakthroughs, expanding access to our medicines, and working to prevent and ultimately cure disease. Novo Nordisk employs about 77,400 people in 80 countries and markets its products in around 170 countries. For more information, visit Facebook, Instagram, X, LinkedIn and YouTube. Contacts for further information Media: Ambre James-Brown +45 3079 9289abmo@ Liz Skrbkova (US)+1 609 917 0632lzsk@ Investors: Jacob Martin Wiborg Rode+45 3075 5956jrde@ Ida Schaap Melvold +45 3077 5649idmg@ Sina Meyer +45 3079 6656azey@ Max Ung+45 3077 6414 mxun@ Frederik Taylor Pitter +1 609 613 0568fptr@ _______________________References1. Chowdary P, Angchaisuksiri P, Apte S, et al. Concizumab prophylaxis in people with haemophilia A or haemophilia B without inhibitors (explorer8): a prospective, multicentre, open-label, randomised, phase 3a trial. Lancet Haematol. 2024;11:e891–e904. doi: 10.1016/S2352-3026(24)00307-7.2. Kahr Rasmussen N, Berg B, Christiansen ASL, et al. The Concizumab Pen-Injector is Easy to Use and Preferred by Hemophilia Patients and Caregivers: A Usability Study Assessing Pen-Injector Handling and Preference. Patient Prefer Adherence. 2024;18:1713–1727. doi: 10.2147/PPA.S470091.3. Angchaisuksiri P, von Mackensen S, Apte S, et al. Concizumab prophylaxis in people with hemophilia A or B without inhibitors: patient-reported outcome results from the phase 3 explorer8 study. Res Pract Thromb Haemost. 2025;9:102705. doi: 10.1016/ Matsushita T, Shapiro A, Abraham A, et al. Phase 3 Trial of Concizumab in Hemophilia with Inhibitors. N Engl J Med. 2023;389:783–794. doi: 10.1056/NEJMoa2216455.5. Alhemo® (concizumab): Summary of Product Characteristics. 2024. Available at: Last accessed: July 2025. 6. Alhemo® (concizumab-mtci): Prescribing Information. 2024. Available at: Last accessed: July 2025. 7. CDSCO. List of new drugs (r-DNA origin) approved for import and marketing in India during Jan, 2020 – Apr, 2025 Available at: Last accessed: July 2025. 8. Alhemo® (concizumab): Brazil Product Information. 2025. Available at: Last accessed: July 2025. 9. Alhemo® (concizumab): Switzerland Product Information. 2024. Available at: Last accessed: July 2025. 10. Alhemo® (concizumab): Japanese Product Information. Available at: Latest revision date: July 2025. 11. Alhemo® (concizumab): Therapeutic Goods Administration (TGA) Product Information. 2024. Available at: Last accessed: July 2025. 12. NCT04082429. Research Study to Look at How Well the Drug Concizumab Works in Your Body if You Have Haemophilia Without Inhibitors (explorer8). Available at: Last Accessed: July 2025. 13. Iorio A, Stonebraker JS, Chambost H, et al. Establishing the Prevalence and Prevalence at Birth of Hemophilia in Males: A Meta-analytic Approach Using National Registries. Ann Intern Med. 2019;171:540–546. doi: 10.7326/M19-1208.14. Centers for Disease Control and Prevention. About Hemophilia. Available at: Last accessed: July 2025. 15. Statista. Distribution of people with bleeding disorders worldwide in 2020, by gender. Available at: Last accessed: July 2025. Attachment PR250725-Alhemo-CHMP-Positive-OpinionSign in to access your portfolio
The Hill
37 minutes ago
- The Hill
New tariffs could raise prices of Ozempic, Wegovy
(NEXSTAR) – A trade deal between the U.S. and the European Union is expected to impose a 15% tax on pretty much all goods imported from Europe, from fancy French wines to sleek German cars and in-demand pharmaceuticals. Some of the most recognizable brand names that could be impacted include Ozempic and Wegovy, two injectable drugs that have grown popular in recent years for their abilities to treat diabetes and promote weight loss. Both are made by Novo Nordisk, a Danish company. But the European drugs are extremely popular here in the U.S. Wegovy – the version of the drug that's FDA-approved to treat obesity – has about 200,000 weekly prescriptions in the U.S., according to Novo Nordisk. Even before the new tariffs, many people have found the medications to be prohibitively expensive. Without insurance, they cost about $500 a month. What is the Presidential Fitness Test? It's usually cheaper for those who can get the drug covered by their health plan. Novo says of its patients who have coverage in the U.S., 85% pay $25 or less per month. After the tariffs take effect, the prices of importing these medications into the U.S. will go up, but who will pay that tax isn't straightforward. Rena Conti, an associate professor at Boston University's Questrom School of Business, told NBC News that drug companies could just raise their price list right away to offset the higher cost. Those without insurance might notice the sticker price change, but those with coverage could end up paying more in higher premiums. 'The big picture is: The cost of imported drugs is about to become more expensive for all Americans,' Joe Brusuelas, principal and chief economist for RSM US, said in an interview with Axios. Other name-brand drugs like Botox, Viagra and Keytruda (a cancer medication) are also manufactured in Europe and impacted by the tariffs. Some drug generics were supposed to be carved out of the deal, but details were still pending as of Thursday. When asked how Ozempic and Wegovy would be impacted by the new 15% tariff, a Novo Nordisk spokesperson told Nexstar the company 'remains focused on improving patient access and affordability, and we will continue to work to find solutions that help people access the medication they need.'
Wall Street Journal
38 minutes ago
- Wall Street Journal
Novo Nordisk's Weight Loss Lesson
Talk about dropping weight fast. See Novo Nordisk's 33.8% stock plunge this past week after it reduced its sales forecast. The Ozempic manufacturer has shed hundreds of billions of dollars in market value over the last year amid stepped-up competition. One lesson is that pharmaceutical cash cows rarely last long. Novo Nordisk slashed its profit forecast owing to slower sales growth for its Ozempic diabetes and Wegovy weight-loss treatments in the U.S. Its blockbuster GLP-1 drugs have been losing market share to Eli Lilly's Mounjaro and Zepbound. The latter has shown greater weight loss than Wegovy in some studies. Lilly is also building on its success with an experimental drug that can increase weight loss from fat and reduce loss of lean muscle mass. Its experimental once-a-day pill has shown comparable efficacy to Ozempic's weekly injectable. A pill would be less expensive to manufacture and more popular among patients. Both Lilly and Novo Nordisk previously struggled to scale up manufacturing to meet enormous demand for their weight-loss drugs. Under Food and Drug Administration rules, specialty pharmacies are allowed to produce knock-offs of drugs on its shortage list. Although the FDA has removed the drugs from its shortage list, some pharmacies continue to manufacturer them.
