Pharmaceutical Executive Editorial Staff Patients with obesity are now able to access Zepbound (tirzepatide) with a prescription at retail and mail-order pharmacies across six dose strengths. Eli Lilly and Company announced today that its obesity treatment Zepbound (tirzepatide) is now commercially available at pharmacies in the United States.1 Last month, the FDA approved Zepbound injection as the first and only approved treatment for obesity that activates both glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) hormone receptors.2 Image credit: Kurhan | stock.adobe.com Patients with obesity are now able to access Zepbound with a prescription at retail and mail-order pharmacies across six dose strengths—2.5 mg, 5 mg, 7.5 mg, 10 mg, 12.5 mg, 15 mg. “Today opens another chapter for adults living with obesity who have been looking for a new treatment option like Zepbound,” said Rhonda Pacheco, group vice president, Lilly Diabetes and Obesity, US, in a press release.1 The ...
Novo Nordisk has made a splash with its GLP-1 drugs that have allowed patients to achieve significant weight loss. Now the Danish company appears on the verge of another breakthrough, showing that the use of its obesity treatment Wegovy can reduce the risk of heart attack in some patients. Perhaps even more importantly, Novo said this weekend in Philadelphia at the American Heart Association (AHA) Scientific Sessions that the cardiovascular benefits gained from Wegovy aren’t due solely to weight loss. The phase 3 SELECT trial showed that use of Wegovy versus placebo lowered the risk of a non-fatal heart attack by 28% and the risk of progression of chronic kidney disease and renal death by 22%. Additionally in the study—which included nondiabetic obese and overweight patients with established cardiovascular disease—Wegovy was found to reduce the risk of heart-related death by 15% and the risk of death by any cause by ...
Pictured: AstraZeneca office in Gothenburg, Sweden/iStock, Wirestock AstraZeneca has signed an exclusive license agreement with Shanghai-based biotech Eccogene for ECC5004, an early-stage investigational oral glucagon-like peptide 1 receptor agonist that is being developed for obesity, type 2 diabetes and other cardiometabolic diseases. Under the terms of the deal announced on Thursday, AstraZeneca will make an upfront payment of $185 million with the potential for nearly $1.83 billion in future clinical, regulatory and commercial milestones. Eccogene will also be eligible for tiered royalties on net product sales. In exchange for its investment, AstraZeneca will have the exclusive global rights to develop and commercialize ECC5004—except in China, where the pharma will share these rights with Eccogene. “We believe this oral GLP-1RA molecule could offer alternatives to current injectable therapies both as a potential monotherapy as well as in combination for cardiometabolic diseases such as type-2 diabetes, as well as for obesity,” Sharon ...
The US Food and Drug Administration (FDA) has issued a warning against the use of the glucose management product, Dr Ergin’s SugarMD Advanced Glucose Support. The regulator asked consumers not to buy and to immediately stop using the product, promoted and sold for blood glucose management due to hidden drug ingredients. Several SugarMD products are sold online on Amazon as supplements for those with type 1 and type 2 diabetes. One of the supplements, GlucoDefense to maintain glucose metabolism is advertised to produce “truly remarkable [results] within just 6 weeks”. In laboratory tests carried out by the FDA, active ingredients glyburide and metformin were confirmed to be present in the drug. Glyburide and metformin are in several FDA drugs used to treat type-2 diabetes that can only be obtained with a prescription. Both of these ingredients can pose a serious risk to consumers. Glyburide can result in unsafe drops in ...
ohnson & Johnson MedTech Worldwide Chair Tim Schmid [Photo courtesy of Johnson & Johnson] Tim Schmid is the new worldwide chair of Johnson & Johnson MedTech and EVP of Johnson & Johnson (NYSE: JNJ)+ following Ashley McEvoy’s announcement today that she plans to resign from the world’s second-largest medical device manufacturer.“We are pleased to have the depth of talent at Johnson & Johnson that allows us to transition to Tim, a respected, results-driven and Credo-based leader,” J&J Chair and CEO Joaquin Duato said in a news release.McEvoy called Schmid “a trusted friend and partner” in a LinkedIn post announcing her resignation. Schmid has worked for New Brunswick, New Jersey-based J&J for three decades, most recently serving as group chair of J&J MedTech Asia Pacific (APAC).“During his tenure, the APAC region has delivered above-market growth and further strengthened our leadership position across multiple businesses,” J&J said. “Mr. Schmid has also been instrumental in elevating the role ...
By George Kramb Pictured: Man preparing Ozempic injection/iStock, imyskin Thanks to TikTok, Ozempic has emerged as this year’s go-to weight loss drug. The current debate revolves around a need to understand Ozempic’s true benefits, unmarred by the overshadowing emphasis on weight loss. Ozempic is not a weight loss drug. It is an injectable prescription medicine used “along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes,” according to its label. As such, it is crucial to recognize its multifaceted nature and the responsible approach it demands. Ozempic’s role in the evolving world of healthcare—and inadvertently weight loss—involves both medical benefits and societal perceptions. The Authentic Benefits of Ozempic Amidst the clamor surrounding Ozempic’s media coverage, it’s imperative to redirect the focus to its true advantages when employed for its designated purposes. Ozempic’s primary function lies in regulating blood sugar levels, offering crucial assistance to ...
By Tristan Manalac Novo Nordisk is ending its Phase III FLOW trial ahead of schedule after an interim analysis of the kidney outcomes study of semaglutide found a very high likelihood of study success, the company announced Tuesday. FLOW, a large randomized, double-blinded and placebo-controlled superiority trial, was assessing the effects of Novo’s GLP-1 agonist semaglutide on the progression of renal impairment and on the risk of renal and cardiovascular mortality in patients with type 2 diabetes and chronic kidney disease (CKD). Semaglutide is the active ingredient in Novo’s diabetes drug Ozempic and weight-loss treatment Wegovy, approved in January 2020 and June 2021, respectively. The study enrolled more than 3,500 patients worldwide and administered semaglutide as an adjunct to standard of care. FLOW’s protocol allowed for an interim analysis once a specific and pre-determined number of primary endpoint events had already occurred. At this interim analysis, an independent Data Monitoring ...
AstraZeneca (AZ) has shared positive results from a late-stage trial evaluating its oral SGLT2 inhibitor Forxiga (dapagliflozin) in children and adolescents with type 2 diabetes (T2D). T2D is the most common type of diabetes, accounting for over 90% of cases worldwide, and its prevalence in children and adolescents is increasing globally. The disease is characterised by pathophysiologic defects leading to elevated glucose levels, which over time contribute to further disease progression. “Despite the growing global burden of T2D among children and adolescents, the treatment options available are currently limited,” said Ruud Dobber, executive vice president, BioPharmaceuticals Business Unit, AZ. “It is well documented that some patients find injectable therapies challenging, making the need for effective oral treatment alternatives paramount,” he added. AZ’s phase 3 T2NOW, which is one of the largest paediatric T2D studies performed to date, assessed the efficacy and safety of Forxiga as an add-on treatment in children ...
By Tristan Manalac Pictured: Illustration of a damaged liver/iStock, Mohammed Haneefa Nizamudeen Results from the Phase IIb SYMMETRY study showed that Akero Therapeutics’ lead candidate efruxifermin failed to significantly reduce liver fibrosis without worsening non-alcoholic steatohepatitis, the company announced on Tuesday. In the 36-week analysis, 22% of patients treated with the 28-mg dose of efruxifermin (EFX) saw at least a one-stage improvement in liver fibrosis with no non-alcoholic steatohepatitis (NASH) worsening, whereas 24% of those given the higher 50-mg dose met this endpoint. Neither dose level was statistically better than placebo, in which group 14% of participants demonstrated at least a one-stage fibrosis improvement without disease worsening. In addition, 21% and 14% of patients in the lower and higher EFX dose groups—respectively— demonstrated NASH resolution alongside fibrosis improvement of at least one stage. These were not significantly better than the 9% rate in the placebo arm, according to Akero. Despite ...
AstraZeneca has announced positive results from the T2NOW Phase III trial for paediatric patients treated with forxiga (dapagliflozin) for the treatment of type 2 diabetes (T2D). Forxiga is an oral sodium-glucose co-transporter-2 (SGLT2) inhibitor that lowers blood glucose levels. The drug is approved in 122 countries to improve glycaemic control in T2D patients in conjunction with diet and exercise. In the EU, paediatric patients above the age of 10 can be administered the drug after positive results from the T2GO study. Forxiga has not yet been approved for paediatric patients in the US. The T2NOW trial results showed a significant reduction in A1C, an average blood sugar marker in patients taking forxiga and metformin, insulin, or both, compared with patients receiving the placebo. Safety results in 10–17-year-olds are consistent with adult patients who take the drug. Forxiga is not the only SGLT2 inhibitor on the market. Invokana (canagliflozin) by J&J ...
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