Mark Franklin’s Post

#Clinicaltrial #NovoNordisk #Weightloss #BioSpace #NewDrugDevlopment #Obesity #Phase III Trial News Drug Development Novo Nordisk to Increased Weight Loss in Phase III Trial The data suggest the high dose nearly closes the efficacy gap with Zepbound. A high dose of Novo Nordisk’s obesity drug Wegovy caused more weight loss than the approved regimen in a Phase III trial, the company said Friday. However, the data suggest Eli Lilly’s rival GLP-1 drug Zepbound may still have an edge over Wegovy. Wegovy, the weight-loss brand of semaglutide, has a recommended maintenance dose of 2.4 mg. Novo ran the Phase III STEP UP trial to evaluate the effect of increasing the maximum dose to 7.2 mg. The trial randomized 1,407 adults with obesity, but not diabetes, to receive either 7.2 mg or 2.4 mg of semaglutide or placebo. After 72 weeks of weekly injections, patients on the 7.2 mg dose had lost 18.7% of their body weight. Novo saw weight loss of 15.6% at the 2.4 mg dose and 3.9% on placebo. One-third of patients on the high dose lost at least 25% of their weight, compared to 16.7% of people taking the lower dose. The results suggest launching the higher dose could increase the weight loss people experience on Wegovy, Novo said.

Novo Nordisk says its obesity drug in higher dose shows 20.7% weight loss The Danish drugmaker's U.S.-listed shares dropped 2.8per cent to $80.72 on Friday, with the company's blockbuster diabetes drug Ozempic and weight-loss treatment Wegovy among the 15 drugs targeted for Medicare price negotiations for 2027 in the United States. #WeightLossDrugs | #ClinicalTrials | #DiabetesCare | #ObesityTreatment | #PharmaNews | #MedicarePriceNegotiations | #HealthInnovation | #PharmaceuticalResearch | #WeightManagement Read more: https://lnkd.in/e2Pk6AFe

GLP-1 drugs could be beneficial for preventing venous thromboembolism in people with type 2 diabetes. A retrospective study presented at the American Society for Hematology (ASH) conference showed that people on a GLP-1 drug and DPP-4 inhibitors (a common diabetes medication that has no association with thrombosis) had a 20% lower risk of developing clots after one year, a 22% lower rate of pulmonary embolism, and 18% lower rate of deep vein thrombosis. While retrospective studies can't say that GLP-1 drugs were the cause for this decrease, it warrants further study. It is known that diabetes and obesity are strong risk factors for thromboembolism, so taking this look is an excellent first step in establishing if GLP-1s can be beneficial at reducing risk.

The FDA approved BridgeBio’s Attruby (acoramidis) for transthyretin amyloid cardiomyopathy (ATTR-CM), competing with Pfizer’s Vyndamax/Vyndaqel and Alnylam’s Amvuttra in a market projected to exceed $10 billion annually. Attruby’s label highlights reductions in hospitalization and mortality, giving it a commercial edge. #FDAApproval #BridgeBio #Attruby #ATTRCM #HeartDisease #BiotechInnovation #DrugDevelopment #RareDiseases #MedicalBreakthrough

Is Eli Lilly’s weight loss drug (Zepbound) better than Ozempic? Maybe so, although this isn’t confirmed. Over 90% of prediabetic obese patients reduced their risks of developing Type 2 diabetes. Lilly is based in Indianapolis, Indiana. The information came from their longest trial of the drug to date. The side effects are closely related to other similar drugs (nausea, diarrhea, vomiting, constipation, etc.) The trial involved over 1000 patients, who received weekly shots for about three years. See article below if interested. #newblogpost #ozempic #Zepbound #tirzepatide #strategicthinking #weightloss #weightlossdrug  https://lnkd.in/e-Jk5net

Innovent Biologics’s Phase III trial of type 2 diabetes treatment meets endpoints Innovent Clinical Development vice-president Dr Lei Qian said: “The results of DREAMS-1 provided high-quality, compelling evidence for T2D treatment in China, particularly in previously untreated patients whose blood glucose was inadequately controlled with diet and exercise alone. The results of another Phase III study DREAMS-2, involving patients with T2D inadequately controlled by oral antidiabetic drugs (OADs), met the study endpoints in May 2024. Together, the two studies demonstrate mazdutide’s comprehensive efficacy in improving glycemic control, promoting weight loss, and enhancing metabolic outcomes in patients with T2D.” - https://lnkd.in/d5MUESkA #clinicaltrials #diabetes

This #asthma #drug is taken by millions. Now scientists have found it in the brain. The findings, presented at a conference in Texas last week, have raised pressure on Australian authorities to better warn patients about the risks of #montelukast. US government researchers unveiled at a conference last week early results from laboratory tests showing the #medication, sold under the brand name Singulair and generically as montelukast, binds to various brain receptors critical to #psychiatricfunction. While the findings, first reported by news agency Reuters, have not been published or peer-reviewed, they are the first glimpse of detailed research being undertaken by the US Food and Drug Administration. The researchers told patient groups the finalised data would not be published for a while but their participation in the conference was “our way of trying to get this information to the public”. When montelukast hit pharmacy shelves in 1998 under the brand name Singulair, it was a blockbuster product for #pharmaceutical company Merck, offering relief in a pill as an alternative to an inhaler. In early advertising, the company said the side effects were so #benign they were “similar to a sugar pill”, while the label said any distribution in the brain was minimal. But by 2019, thousands of reports of #neuropsychiatric episodes, including dozens of #suicides, in patients prescribed the drug had piled up on internet forums and in the #FDA’s tracking system In Australia, drugs containing montelukast have been associated with more than 200 #adverseevents reported to the #TherapeuticGoodsAdministration in the past decade. There have been 15 events reported this year alone, including three suicides. Montelukast was the only drug the three people who took their own lives were known to have been taking at the time of their deaths. However, “adverse event” reports are not confirmed by the #TGA and do not prove a causal link between a medicine and a side effect. In 2020, increasing adverse event reports in the US, combined with new scientific research, led the FDA to add a “black box” warning to the montelukast prescribing label, signalling serious #mentalhealth risks. The agency also convened a group of internal experts about the same time to look into why the drug might trigger neuropsychiatric side effects. Jessica Oliphant, a deputy director at the FDA’s National Centre for Toxicological Research, told the conference that laboratory tests showed “significant binding” of montelukast to receptors in the brain. The FDA confirmed earlier scientific research showing montelukast penetrates the brains of rats. “These data indicate that montelukast is highest in brain regions known to be involved in [psychiatric effects],” Oliphant said. https://lnkd.in/gUc_8kRV

📊 AMNOG Regulation & Willingness to Pay in Germany A study by Büssgen & Startgardt (2023) analyzed the impact of the AMNOG (Arzneimittelmarkt-Neuordnungsgesetz) regulation in Germany and shed light on the implicit willingness-to-pay (WTP) for newly authorized drugs in three major diseases: diabetes, cardiovascular disease, and psoriasis. 🔬 Key Results: - Diabetes: WTP of €33,814 per 1% HbA1c reduction for new drugs. - Cardiovascular Disease: WTP of €10,971 per life year gained. - Psoriasis: WTP of €663 per 1% PASI decrease, translating to €33,173 for a clinically important 50% reduction. Full article available here: https://lnkd.in/eCTyxzQP WTP findings are crucial for increasing transparency and understanding how payer perspectives influence pharmaceutical market access and pricing policies. In addition, they are one of the key assumption in our models. Yet, there are still few of them. For AMNOG regulation, for instance, a quick PubMed search gave me only 5 hits. How can we start bridging the gap between health economic modelling and policy analysis? #HealthEconomics #AMNOG #PharmaceuticalPricing #Germany #WillingnessToPay #HealthPolicy #MarketAccess

🔬 MHRA Finds No Causal Link Between GLP-1 Receptor Agonists and Suicidal or Self-Injurious Behavior Following a comprehensive review, the Medicines and Healthcare products Regulatory Agency (MHRA) has concluded that current evidence does not support a link between Glucagon-Like Peptide-1 (GLP-1) receptor agonists (such as exenatide, liraglutide, dulaglutide, and semaglutide) and suicidal thoughts, self-injury, or depression. This assessment follows an earlier safety review initiated in July 2023 after concerns were raised from post-marketing reports. After analyzing clinical trial data, epidemiological studies, and scientific literature, the MHRA’s findings align with European regulatory reviews, confirming no updates to product information are required at this time. 💡 Key Points: Available data does not establish a causal link between GLP-1 receptor agonists and severe psychiatric reactions. Ongoing monitoring of these medicines will continue to ensure patient safety. The MHRA remains committed to evaluating new data as it emerges. Ensuring patient safety is always a priority, and the MHRA will continue its vigilance in assessing any new risks associated with these widely-used treatments. Full information: https://lnkd.in/etuEzkGQ #Pharmaceuticals #PatientSafety #MHRA #GLP1ReceptorAgonists #Healthcare #RegulatoryAffairs #MedicalResearch #DrugSafety #Pharma