Novo Nordisk’s diabetes drug Victoza is now approved in Europe as the only GLP-1 analogue with a label including prevention of cardiovascular events.
Denmark-based, Novo Nordisk developed a drug that stimulates insulin productions called semaglutide a class of drugs which categorized in GLP-1s. The new oral diabetes medicine is a better lowering blood sugar levels compared to the existing drug.
Novo Nordisk announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) voted 16-0 in favour of the approval of once-weekly semaglutide to improve glycaemic control in adults with type 2 diabetes. One member of the committee abstained.
Don Tracy, Associate Editor In the Phase IIIa FRONTIER 2 trial, participants aged 12 years and older administered Mim8 showed significant and superior reduction of treated bleeding episodes. Novo Nordisk announced successful results from the Phase IIIa FRONTIER 2 trial, which evaluated the efficacy and safety of Mim8, a promising new treatment for hemophilia A. According to the company, this trial enrolled 254 participants over the age of 12 years to analyze the efficacy and safety of once-weekly and once-monthly subcutaneous Mim8 versus no prophylaxis and versus prior coagulation factor prophylaxis treatment. The trial met its two primary endpoints, which were to demonstrate significant and superior reduction of treated bleeding episodes with both once-weekly and once-monthly administration of Mim8.1 “We are very pleased with the positive results from the FRONTIER 2 clinical trial. These data demonstrate the ability of Mim8 to prevent bleeding episodes effectively and safely in people with ...
Amgen’s total revenues grew in Q1 2024 to $7.4bn, displaying a 22% increase from earnings reported in the first quarter of last year. The company reported an operating income of $3.1bn, on a non-GAAP [generally accepted accounting principles] basis. The non-GAAP earnings per share (EPS) dipped 1% to $3.96, with the decrease attributed to higher operating and interest expenses that resulted from the acquisition of Horizon Therapeutics. Amgen acquired Horizon for $27.8bn (£22.76bn) following approval from the US Federal Trade Commission (FTC) in October 2023. The revenue growth was driven by a 22% increase in product sales and a 25% volume growth, with ten products achieving double-digit volume growth. Key performers included hyperlipidemia immunotherapy Repatha (evolocumab) and osteoporosis treatment in postmenopausal women Evenity (romosozumab-aqqg), which grew 33% year-over-year (YoY) and 35% YoY respectively in Q1. Amgen also reported an 80% YoY growth for the severe asthma medication Tezspire (tezepelumab-ekko), and ...
Upcoming weekly insulin candidates can reduce the injection burden on patients with diabetes and ease the load on healthcare resources, said Anna Hodgkinson, a specialist diabetes pharmacist at an ongoing diabetes conference in London. Hodgkinson, who works at at the Lambeth Diabetes Intermediate Care Team, called particular attention to Novo Nordisk’s Awiqli (insulin icodec) and Eli Lilly’s LY3209590 (insulin efsitora alfa), both of which are weekly insulin candidates that may be available on the market shortly. She was speaking at a talk at the Diabetes UK conference on 17 April. The conference closes on 19 April. Despite the benefits, Hodgkinson raised questions about whether Awiqli’s long half-life may prolong the time required for insulin clearance. The therapy is still yet to be tested in chronic kidney disease patients, Hodgkinson added. Awiqli is a long-acting basal insulin analogue with a half-life of 196 hours (8.1 days). Its treatment regimen involves three ...
Mike Hollan BrandShield states that it has identified sites selling counterfeit versions of Wegovy and Ozempic, among other drugs. It’s important to always be careful whenever buying anything from a website, especially medication. In recent years, it’s become much more common for patients and other consumers to find online sources where they can directly access medications without having to visit a pharmacy. This provides clear benefits for patients, such as limiting the burden placed upon them and potentially helping to reduce the cost of some medications. As is the case with most things, however, there are also risks. A new report from Reuters details one company’s work to take down sites selling fake medications.1 Not surprisingly, a significant percentage of these sites were selling counterfeit weight-loss drugs, such as fake versions of Ozempic. The report does note, however, that the number of sites selling these counterfeit weight-loss drugs has significantly ...
Biopharmaceutical companies are regaining interest in metabolic dysfunction-associated steatohepatitis (MASH) innovator drug development. MASH innovator drugs witnessed over $2.5 billion increase in the total value of partnership deals from 2020 to 2024 year-to-date (YTD), with more than $2 billion forged in Q1 2024 alone, reveals GlobalData. MASH, previously known as nonalcoholic steatohepatitis (NASH), is a disease characteriSed by liver inflammation and damage caused by the accumulation of fat. Madrigal Pharmaceuticals’ Rezdiffra (resmetirom), a small molecule THRB agonist, was the first drug approved by the FDA for MASH in March 2024. Alison Labya, Business Fundamentals Analyst at GlobalData, comments, “Interest in MASH has returned in light of the FDA approval of Madrigal’s Rezdiffra, as well as the success of GLP-1 obesity drugs and their potential efficacy in MASH, as demonstrated by Eli Lilly’s Zepbound (tirzepatide; also known as Mounjaro for type 2 diabetes) in its Phase II SYNERGY-NASH trial readout.” However, ...
Mike Hollan The medical side of the market is growing while the commercial side seems to be struggling. A new study reveals just how strong of a year 2023 was for the weight loss drug industry. Anti-obesity medications (AOMs) have seen a surge in popularity over the past year. This is due to a variety of factors, including the increase in demand for drugs like Wegovy and Ozempic. The two drugs became so popular in 2023 that Wegovy’s developer Novo Nordisk had to temporarily limit the supply of lower, beginner doses of the medication. While it’s clear that AOMs had a good year in 2023, a new report details the heights of that success. According to a study conducted Marketdata LLC and published in Research and Markets, the weight loss market in 2023 rose to a historic peak. In a press release,1 Research and Markets explains that the boom in ...
Insulin prices have long been a pain point for diabetics. The big three insulin manufacturers have cut prices across their product lineups, but potential competition from other biosimilar insulins is still in earlier stages of development. By FRANK VINLUAN Inflation remains a top consumer gripe, but the higher cost of milk and eggs is negligible when compared to insulin. Spending on insulin has tripled in the past decade, topping $22 billion in 2022, according to research from the American Diabetes Association. While some of that increase is due to a growing patient pool, it’s also due to rising prices. The inflation-adjusted cost of insulin increased 24% from 2017 to 2022. Lower-cost insulin is becoming available to more Americans with diabetes. Implementation of the Inflation Reduction Act last year was a catalyst. One of the federal law’s provisions set a $35 cap on the monthly out-of-pocket cost for insulin. Though the ...
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