Wegovy (semaglutide injection once weekly) / Novo Nordisk - LARVOL DELTA

Biocon eyes generic Wegovy obesity drug launch in India, Canada in next 2 years, CEO says (Reuters) - "Biocon...opens new tab aims to launch generic copies of the blockbuster weight-loss drug Wegovy in India and Canada within the next two years, a top executive told Reuters, seeking to tap into a market that is estimated to grow to $150 billion globally by the early 2030s."

Commercial • Obesity

Novo Nordisk A/S: New Wegovy dose submitted to European Medicines Agency for approval, with 1 in 3 trial participants achieving 25% or more weight loss (Novo Nordisk Press Release) - "Novo Nordisk...announced the submission of an application to the European Medicines Agency (EMA) for approval of a new, higher dose of its obesity treatment, Wegovy (subcutaneous semaglutide 7.2 mg)...The submission to the EMA is based on clinical data from the STEP UP and STEP UP T2D trials, investigating the efficacy and safety of semaglutide 7.2 mg in adults with obesity in STEP UP, and adults with obesity and type 2 diabetes in STEP UP T2D."

EMA filing • Obesity

Wegovy, injectable drug used to treat obesity, now available via prescription in Singapore (Straits Times) - "An injectable drug used to treat obesity is now available via prescription from any licensed physician at hospitals and clinics across Singapore. In a statement on July 12, pharmaceutical firm Novo Nordisk said the launch of Wegovy locally is to support Singapore’s efforts in improving population health. Wegovy is suitable for adults who are obese, or those who are overweight with at least one weight-related comorbidity such as high blood pressure, type 2 diabetes or high cholesterol."

Launch non-US • Obesity

PILLAR: A Two-year Prospective, Observational Study of Wegovy in Real-world Clinical Practice (clinicaltrials.gov) - P=N/A | N=1250 | Not yet recruiting | Sponsor: Novo Nordisk A/S

New trial • Real-world evidence • Genetic Disorders • Obesity

U.S. telehealth upstart plans to sell generic Ozempic in Canada as patent due to lapse (Yahoo Finance) - "U.S. telehealth upstart Hims & Hers Health, Inc. is planning to enter the Canadian market with an eye to selling generic semaglutide, the anti-diabetic medication used for the treatment of type 2 diabetes that is growing popularity as an anti-obesity medication...The opportunity for Hims and Hers comes as Danish pharmaceutical giant Novo Nordisk is set to lose Canadian patent protection on its popular semaglutide-based drugs, Ozempic and Wegovy, after apparently failing to pay a small fee to maintain the patent...Meanwhile, it will hold the patent in the United States until at least 2032...In a press release, Hims and Hers said almost two-thirds of adults in Canada are overweight or living with obesity. Branded semaglutide with no surrounding clinical support currently costs more than $200 a month in Canada....It said the price for generic semaglutide is expected to be available at a significant discount to the branded versions, with the prices expected to lower over time."

Commercial • Diabetes • Obesity

Wegovy: “Extension of indication to include risk reduction of major adverse cardiovascular events…in adults with established cardiovascular disease and BMI ≥27 kg/m2 for WEGOVY, based on results from study EX9536-4388 (SELECT)…as a consequence, sections 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated” (European Medicines Agency) - CHMP Final Minutes of the meeting on 22 - 25 Jan 2023: “The committee adopted a request for supplementary information with a specific timetable”

European regulatory • Metabolic Disorders • Obesity

Health Canada approves Wegovy (semaglutide injection) to reduce the risk of non-fatal myocardial infarction (Novo Nordisk Press Release) - "Novo Nordisk announced today that Wegovy (semaglutide injection) is now approved to reduce the risk of non-fatal myocardial infarction in adults with established cardiovascular disease and BMI equal to or greater than 27 kg/m2. It is the first Health Canada approved treatment to support both chronic weight management and to reduce the risk of non-fatal MI. Health Canada’s non-fatal MI indication for Wegovy is based on results of the Semaglutide Effects on Cardiovascular Outcomes in People with Overweight or Obesity (SELECT) trial."

Canada approval • Metabolic Disorders • Myocardial Infarction • Obesity

Wegovy: “Extension of indication to include risk reduction of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and BMI ≥27 kg/m2 for WEGOVY, based on results from study EX9536-4388 (SELECT)… as a consequence, section 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated” (European Medicines Agency) - CHMP Final Minutes of the meeting on 22- 25 Apr 2024: “The committee adopted a 2nd request for supplementary information with a specific timetable”

CHMP • Metabolic Disorders • Obesity

Wegovy: Newly added patent in Orange Book (Orange Book) - Expiry on Oct 10, 2038

Patent • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Nemaura Launches Direct to Consumer Offering of Metabolic Health Program in Combination with GLP-1 Weight Loss Drugs (GlobeNewswire) - "Nemaura Medical...announced the UK launch of its ground-breaking approach to metabolic health and weight management by integrating continuous glucose monitoring (CGM) with its behavioral change program, Miboko, complemented by pharmaceutical interventions using GLP-1 agonists such as Ozempic, Wegovy and Mounjaro. This innovative offering, featuring education, lifestyle modifications, dietary guidance, exercise goals, and cutting-edge glucose monitoring, represents a significant advancement in personalized weight loss strategies addressing the metabolic health, obesity and diabetes markets."

Clinical • Cardiovascular • Diabetes • Metabolic Disorders • Obesity

Wegovy: “Extension of indication to include risk reduction of major adverse cardiovascular events (cardiovascular death, non-fatal myocardial infarction, or non-fatal stroke) in adults with established cardiovascular disease and BMI ≥27 kg/m2 for WEGOVY, based on results from study EX9536-4388 (SELECT)…as a consequence, section 4.1, 4.2, 4.8 and 5.1 of the SmPC are updated.” (European Medicines Agency) - CHMP Final Minutes of the meeting on 24- 27 Jun 2024: “The committee adopted a 3rd request for supplementary information with a specific timetable.”

CHMP • Metabolic Dysfunction-Associated Steatotic Liver Disease

European regulatory authority adopts a positive opinion for an update of the Wegovy label to reflect risk reduction of major adverse cardiovascular events (GlobeNewswire) - "Novo Nordisk today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for an update of the Wegovy (semaglutide 2.4 mg) label to reflect data from the SELECT cardiovascular outcomes trial, demonstrating a risk reduction of major adverse cardiovascular events (MACE) including cardiovascular death, non-fatal heart attack (myocardial infarction) or non-fatal stroke in adults with established cardiovascular disease (CVD) and either overweight or obesity (initial BMI ≥27 kg/m2) without diabetes."

CHMP • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk A/S: Semaglutide 2.4 mg (Wegovy) cardiovascular outcomes data presented at American Heart Association Scientific Sessions and simultaneously published in New England Journal of Medicine (GlobeNewswire) - P3 | N=17,609 | SELECT (NCT03574597) | Sponsor: Novo Nordisk A/S | "Novo Nordisk today announced the primary results of SELECT...Analyses of the three components in MACE showed that the risk of non-fatal myocardial infarction or heart attack was reduced by 28% compared to placebo (HR: 0.72; 95% confidence interval: 0.61; 0.85), the risk of cardiovascular death was reduced by 15% (HR: 0.85; 95% confidence interval: 0.71; 1.01, not statistically significant over the length of the trial) and the risk of non-fatal stroke was reduced by 7% compared to placebo (HR: 0.93; 95% confidence interval: 0.74;1.15, not statistically significant over the length of the trial)....Novo Nordisk has filed for a label update of Wegovy in the US and EU....A decision is expected in 2024. The Food and Drug Administration (FDA) recently granted priority review for the addition of the SELECT data to the label for Wegovy in the US."

FDA event • P3 data • Cardiovascular • Diabetes • Metabolic Disorders • Obesity

Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 23-26 October 2023 (European Medicines Agency) - "EMA’s safety committee (PRAC) has concluded that the available evidence does not support a causal association between the Glucagon-Like Peptide-1 Receptor Agonists (GLP-1) - exenatide, liraglutide, dulaglutide, semaglutide, and lixisenatide - and cancer of the thyroid (a small gland in the front and lower part of the neck which makes and releases hormones)....The MAHs for liraglutide- (including Victoza, Saxenda, Xultophy), semaglutide- (including Ozempic, Rybelsus, Wegovy), exenatide- (including Bydureon, Byetta), dulaglutide- (i.e.Trulicity) and lixisenatide- (including Lyxumia, Suliqua) containing products should continue to monitor these events closely, including any new publications, as part of their pharmacovigilance activities and report any new evidence on this issue in their Periodic Safety Update Reports (PSURs)."

European regulatory • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

FORM, The Virtual Obesity Medicine Clinic, Launches FORMfit, A New Program Helping Employers Expand Access to High-Quality Obesity Care While Controlling Costs (Businesswire) - "Today, FORM...officially launched FORMfit, a new program helping employers expand access to high-quality, clinical obesity care while managing costs. The past year has seen surging consumer demand for and rapid adoption of expensive GLP-1 receptor agonists like OzempicⓇ and WegovyⓇ. As a result, many employers have seen their pharma costs skyrocket and, in response, moved to completely restrict access to these highly effective drugs to control costs. FORM developed its proprietary offering, FORMfit, to allow employers to expand access to high-impact obesity care while investing in GLP-1s at a level that aligns with their short and long-term goals and budget constraints."

Reimbursement • Cardiovascular • Metabolic Disorders • Obesity

Novo Nordisk launches national Wegovy campaign, Power of Wegovy (PRNewswire) - "Novo Nordisk today launched The Power of Wegovy, a new national campaign. The campaign aims to educate on the clinical data of Wegovy (semaglutide) 2.4 mg injection and reflect the collective empowerment people living with obesity can feel when they don't have to manage their weight alone....As we continue to make progress on increasing supply for Wegovy (WegovySupply.com) to meet continued demand, Novo Nordisk is equally focused on reinforcing the U.S. Food and Drug Administration (FDA) approved uses for Wegovy among patients and the general public, which this campaign will support."

Commercial • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Wegovy (semaglutide injection) available in Canada (Canada Newswire) - "Novo Nordisk has announced that Wegovy Health Canada approved product monograph on May 6, 2024....Wegovy will provide additional support for people living with obesity – a serious medical condition. Ongoing high global demand for Wegovy speaks to the considerable unmet need for treatment options. Novo Nordisk will work closely with healthcare providers and regulators to continually assess the level of need along with available supply to help ensure that patients who start treatment can remain on treatment."

Launch Canada • Metabolic Disorders • Obesity

Novo Nordisk’s sales increased by 25% in Danish kroner and by 26% at constant exchange rates to DKK 290.4 billion in 2024 (GlobeNewswire) - "Wegovy sales increased by 86% in both Danish kroner and at CER to DKK 58,206 million. Sales of Saxenda decreased by 33% measured in Danish kroner and by 32% at CER to DKK 6,940 million as the obesity care market is moving towards once-weekly treatments...Sales of Obesity care products in North America Operations increased by 45% in both Danish kroner and at CER to DKK 48,158 million. Sales of Wegovy increased by 59% in both Danish kroner and at CER to DKK 46,781 million...Sales of Saxenda decreased by 65% measured in Danish kroner and by 64% at CER to DKK 1,377 million. The volume growth of the branded obesity market in the US was 152%...Sales of Obesity care products in EMEA increased by 83% in both Danish kroner and at CER to DKK 10,433 million driven by Wegovy, partially countered by declining Saxenda sales...Sales of Obesity care products in Region China increased by 104% measured in Danish kroner and by 108% at CER to DKK 298 million."

Sales • Obesity

FDA declares Wegovy and Ozempic shortage is over and that Novo Nordisk is fully meeting or exceeding nationwide demand for all doses (PRNewswire) - "Novo Nordisk announced that the U.S. Food and Drug Administration (FDA) has determined the shortage of Wegovy and Ozempic is resolved. The FDA's assessment confirms the U.S. supply of these prescription-only GLP-1 medicines now meets or exceeds both current and projected U.S. demand....We continue to operate production facilities 24 hours a day, seven days a week with all doses of Wegovy and Ozempic being shipped regularly to wholesalers. This update comes after ongoing dialogue with the FDA, and substantial efforts by Novo Nordisk to increase manufacturing capacity, including $6.5 billion dollars of investments in the U.S. this year alone."

Commercial • Obesity

Wegovy: Newly added patent in Orange Book (Orange Book) - Expiry on Aug 24, 2038

Patent • Cardiovascular • Diabetes • Metabolic Disorders • Obesity • Type 2 Diabetes Mellitus

Novo Nordisk A/S: Semaglutide 2.4 mg reduces the risk of major adverse cardiovascular events by 20% in adults with overweight or obesity in the SELECT trial (GlobeNewswire) - P3 | N=17,609 | SELECT (NCT03574597) | Sponsor: Novo Nordisk A/S | "Novo Nordisk today announced the headline results from the SELECT cardiovascular outcomes trial. The double-blinded trial compared subcutaneous once-weekly semaglutide 2.4 mg with placebo as an adjunct to standard of care for prevention of major adverse cardiovascular events (MACEs) over a period of up to five years....The trial achieved its primary objective by demonstrating a statistically significant and superior reduction in MACE of 20% for people treated with semaglutide 2.4 mg compared to placebo....Novo Nordisk expects to file for regulatory approvals of a label indication expansion for semaglutide 2.4 mg (Wegovy) in the US and the EU in 2023. The detailed results from SELECT will be presented at a scientific conference later in 2023."

P3 data • Metabolic Disorders • Obesity

Evernorth to Expand Weight Management Program to include Wegovy (PRNewswire) - "'Our comprehensive program helps ensure adherence to therapy, reduces discontinuation, and provides ongoing lifestyle and behavioral changes that may lead to prevention of other health conditions that can result from obesity, such as diabetes and heart disease,' said Dr. John Wigneswaran...'Evernorth's comprehensive strategy, coupled with the promising early results of Wegovy, may help patients achieve sustainable weight loss and plans achieve tremendous long-term cost-savings.'"

Media quote

Novo Nordisk introduces NovoCare Pharmacy, lowering cost of all doses of FDA-approved Wegovy (semaglutide) to $499 per month and offering easy home delivery for cash-paying patients (PRNewswire) - "As part of its ongoing efforts to ensure patients who need Wegovy (semaglutide) injection 0.25 mg, 0.5 mg, 1 mg, 1.7 mg, and 2.4 mg can access it, Novo Nordisk launched NovoCare Pharmacy, a direct-to-patient delivery option that offers cash-paying patients all dose strengths of Wegovy at a reduced cost of $499 per month. This offer is available for uninsured patients or eligible patients with commercial insurance who do not have coverage for obesity medicines. NovoCare Pharmacy expands the company's toolkit of offerings to meet the diverse needs of people living with obesity. This announcement follows the recent FDA decision that the shortage of this medicine is resolved, with all dose strengths of Wegovy meeting or exceeding both current and projected U.S. demand."

Commercial • Obesity

Humbi AI by Innovaccer and Landmark Science to Present Real-World Evidence on GLP-1 Use for Cardiometabolic and Cardiovascular Risk Reduction in Medicare Populations at ISPOR 2025 (Businesswire) - "Innovaccer...announced that its recently acquired actuarial science company - Humbi AI, in collaboration with Landmark Science, Inc., will present a joint research at the upcoming International Society for Pharmacoeconomics and Outcomes Research (ISPOR) 2025 annual conference, scheduled to take place between May 13–16 in Montreal, QC, Canada...The research offers new insights into the characteristics of Medicare patients initiating GLP-1 receptor agonists (RAs) and Wegovy (semaglutide) for cardiometabolic and cardiovascular risk reduction...The research, leveraging Humbi AI’s high-quality real-world Medicare dataset, provides a timely look into patient populations initiating these therapies—an area of growing importance as GLP-1 RAs expand beyond diabetes management."

Real-world evidence • Cardiovascular

Novo Nordisk protects US patients with legal wins against compounders, including ruling that permanently prohibits compounding pharmacy from selling illegitimate, knockoff Wegovy or Ozempic (PRNewswire) - "Yesterday, a Texas federal court ruled in favor of Novo Nordisk and FDA, denying a compounding trade association's motion to freeze the FDA's decision to end the shortage of semaglutide injectable medicines. The court's ruling left in place FDA's prior determination that all doses of Wegovy and Ozempic are fully available nationwide and that Novo Nordisk's supply of these FDA-approved medicines is meeting or exceeding current and projected nationwide patient demand....This latest win on behalf of patients follows another key decision by the District Court for the Southern District of Texas, where a federal judge entered a final judgment and permanent injunction in favor of Novo Nordisk, against a 503A pharmacy, MediOak Pharmacy LLC, permanently prohibiting them from marketing or selling compounded 'semaglutide' knockoff drugs."

Commercial • Obesity • Type 2 Diabetes Mellitus