LuMind IDSC Foundation’s Post

This week, a panel of independent advisors to the Food and Drug Administration (FDA) recommended approval of Eli Lilly and Company's new Alzheimer’s drug, donanemab. This recommendation paves the way for #donanemab to receive FDA approval in the U.S. later this year, marking a significant milestone in the battle against a disease that affects millions of individuals and their families worldwide. The panel’s recommendation is based on compelling data from Eli Lilly’s clinical trial program in 2023. In the pivotal Phase 3 study, donanemab demonstrated a significant slowing of cognitive and functional decline in patients with early symptomatic Alzheimer’s disease. Results showed that patients treated with donanemab experienced a substantial reduction in the progression of the disease compared to those receiving placebo. What does this mean for patients? Per Joel Salinas, MD, MBA, MSc, FAAN, “This recommendation means that an external panel believes that donanemab has shown promising results in slowing cognitive decline in early symptomatic stages of #Alzheimers. Now, the remaining step is for the FDA to give its review.” Read more about donanemab in our blog post 👉 https://lnkd.in/eCr9CVx8

Last week Eli Lilly and Company got a strong sign that it's new anti-amyloid drug for Alzheimer's will be approved, inviting the question: which of Lilly's blockbusters will do more to stave off Alzheimer's in coming decades ... it's anti-amyloid drug purpose-built for Alzheimer's, or it's GLP-1 drugs that reverse metabolic disease? News from the American Diabetes Association meeting next week will only cloud the picture, mixing reports of amazing GLP-1 results with cautionary tales about side effects, inconsistent prescribing practices, high prices, and insurer-imposed barriers. It's time for us to redefine how we think and talk about GLP-1s, shifting the focus from weight loss - with all the stigma that entails - to reversing or stopping metabolic disease. This mindset shift enables us to think anew about how to price, ensure that patients get more than just an Rx. It IS possible to make GLP-1s widely available and affordable, reducing upfront prices and paying on outcomes over time, with Medicare getting deep discounts in exchange for minimum purchase commitments. Everyone can win - drug companies, the government, employers, and insurers. And, most of all, Americans now on the road to advanced metabolic disease and dementia.  

Repurposing resources: 1. The Potential of a Stratified Approach to Drug Repurposing in Alzheimer’s Disease https://lnkd.in/dwVXdwgC by Chloe Anderson, Magda Bucholc, Paula McClean and Shu-Dong Zhang 2. Repurposed agents in the Alzheimer’s disease drug development pipeline https://lnkd.in/dBZXRfXA by Justin Bauzon, Garam Lee & Jeffrey Cummings Further relevant posts: 1) Resources for data science driven drug repositioning efforts in Alzheimer's https://lnkd.in/gd7q-RqV 2) Drug repositioning for Alzheimer’s disease (2012)  https://lnkd.in/d62GnndG 3) Alzheimer's Drug Development Pipeline 2024 https://lnkd.in/dAMssPM5 4) Will the first effective Alzheimer's treatment be a repurposed drug? (2014) asks Alzheimer's Drug Discovery Foundation blog available at https://lnkd.in/dBUm2ATN 5) Alzheimer's Disease International considers When will there be a cure? https://lnkd.in/gzCyYCWR 6) Alzheimer’s Disease: Key Insights from Two Decades of Clinical Trial Failures (2022) https://lnkd.in/gvnqQSeh

Merck shares traded more than 4% higher after it won US Food and Drug Administration (FDA) approval for its lung disorder drug sotatercept, brand name WINREVAIR.  After being granted breakthrough therapy designation by the agency, the drug is now the first FDA-approved activin signalling inhibitor therapy for pulmonary arterial hypertension (PAH), a rare, progressive and life-threatening disease where the blood vessels in an individual’s lungs thicken and narrow and cause strain on the heart.   The approval is based on results from the Phase 3 STELLAR study which showed WINREVAIR in combination with background therapy significantly improved participants’ exercise capacity when compared with background therapy alone. More at #Proactive #ProactiveInvestors #NYSE #ETR #MRK #6MK http://ow.ly/EU6T105nv3E

Continuing on from my post yesterday, today's post will focus on Alzheimer's Disease (AD). AD is the most common type of dementia and is pathologically characterized by amyloid plaques and tau tangles and behaviourally characterized by a gradual decline in memory. The treatment of AD has evolved significantly over the years, with various drugs targeting different aspects of the disease's progression. Here's a brief history: 💊 Cholinesterase Inhibitors (1993 onwards): The first class of drugs approved for Alzheimer's treatment were cholinesterase inhibitors. These drugs, including tacrine (Cognex), donepezil (Aricept), rivastigmine (Exelon), and galantamine (Razadyne), work by increasing levels of acetylcholine, a neurotransmitter involved in memory and learning.Tacrine was the first drug approved by the FDA in 1993, but its use declined due to safety concerns and the development of more effective alternatives. ⚕ NMDA Receptor Antagonist (2003): Memantine (Namenda) was approved by the FDA in 2003 as the first drug in a new class of Alzheimer's medications. It works by modulating the activity of glutamate, another neurotransmitter involved in learning and memory, and is believed to protect brain cells from excessive stimulation. 💊 ⚕ Combination Therapy: In some cases, healthcare providers may prescribe a combination of cholinesterase inhibitors and memantine to provide synergistic effects in managing symptoms of Alzheimer's disease. 🏥 Research and Clinical Trials: Numerous other drugs have been studied in clinical trials for Alzheimer's treatment, targeting various aspects of the disease such as amyloid plaque accumulation, tau protein tangles, inflammation, and oxidative stress. However, many of these drugs have failed to show significant efficacy in late-stage trials, leading to disappointment in the search for a definitive cure or disease-modifying treatment. 👨🔬 Biogens Aducanumab (2021): In June 2021, the FDA granted accelerated approval to aducanumab (brand name Aduhelm) for the treatment of AD. Aducanumab targets amyloid beta, a protein that forms plaques in the brains of people with Alzheimer's disease. The approval was controversial due to conflicting evidence regarding the drug's efficacy, with some clinical trials showing modest benefits while others did not demonstrate significant improvement in cognitive function. The New York Times article below, focusing on Eli Lilly and Companys latest therapy to try and treat AD shows the complexity of getting these drugs over the line. The FDA has postponed its decision on the drug, donanemab, opting for further review by an independent panel of experts, surprising both experts and the drug's manufacturer. The delay reflects the FDA's cautious approach, particularly in evaluating unique trial designs and addressing concerns about treatment cessation and the role of tau proteins. https://lnkd.in/e3uE8Ptj

Thoughts on this? >> Pricing For Rare Disease Therapies And Cures What's Fair - Life Science Leader Magazine >> Comment below! >>> lqventures.com #strategy #competitiveintelligence #marketing #biotech #pharma #healthcare #competitivemarketing #pharmaceutical

More than 1 new drug approved per week. And most are in dire need as they are used in rare diseases. Great news for innovation and Pharma #InnovationInHealthcare 💊 #Pharmaceutics🌍 #MedicalResearch #HealthcareProgress #FDA #CDER #NoveldrugApprovals #orphandrugs #rarediseases #55NovelDrugs

Groundbreaking Medical Innovations in 2023: FDA approvals Incredible advancements in #HealthcareInnovation for 2023! 🎉 The FDA's Center for Medication Evaluation and Research (CDER) has approved 55 innovative medications for sale in the U.S. 🇺🇸 These treatments focus on a wide range of diseases from infectious diseases to neurological disorders and various types of tumors. 🏥 51% of these drugs that received orphan drug status, targeting rare diseases such as Friedreich's ataxia, Rett syndrome, and paroxysmal nocturnal hemoglobinuria. 🎗️ Also, hats off to CDER for beating their Prescription Drug User Fee Act (PDUFA) goal dates for 89% of these new medications! 👏 These approvals highlight the crucial role of #InnovationInHealthcare 💊🌍 #MedicalResearch #HealthcareProgress #FDA #CDER #NoveldrugApprovals #orphandrugs #rarediseases #55NovelDrugs https://lnkd.in/dhC-jw2u

Novo Nordisk's study on Ozempic shows promising results, with a 24% reduction in the risk of major cardiac events and death in diabetes patients. GLP-1 drugs like Ozempic may offer broader medical benefits beyond diabetes treatment. This could significantly impact healthcare, especially for the 40% of type 2 diabetes patients affected by chronic kidney disease globally. Novo Nordisk's shares have surged due to the success of its drugs based on semaglutide. The study suggests Ozempic could become a crucial treatment for type 2 diabetes and chronic kidney disease. Eli Lilly is also exploring similar benefits with its GLP-1 drug. #ozempic #pharma #pharmaceutical #pharmaceuticals