Dean Brenner’s Post

I'm not sure if this is what we were waiting for: Per an FDA document, treatment-emergent adverse events (TEAEs) were reported by 89% of donanemab-treated patients. The most common AEs were amyloid-related imaging abnormalities (ARIA)–edema/effusions (ARIA-E; 24%), ARIA-hemorrhage/hemosiderin deposition (ARIA-H; 18%), COVID-19 (14%), fall (13%), and headache (13%). Serious AEs were reported by 17% of donanemab-treated patients. To make it worse, in TRAILBLAZER-ALZ clinical trial, 27.5 % experienced ARIA-E and 30.5% of donanemab patients had ARIA-H. Alzheimer's Association should not wait to recommend interventions. Plenty of nonpharmaceutical interventions have been proven to be significantly more effective than Donanemab in well-designed clinical trials. Some even reversed the cognitive decline.

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I'm not sure if this is what we were waiting for: Per an FDA document, treatment-emergent adverse events (TEAEs) were reported by 89% of donanemab-treated patients. The most common AEs were amyloid-related imaging abnormalities (ARIA)–edema/effusions (ARIA-E; 24%), ARIA-hemorrhage/hemosiderin deposition (ARIA-H; 18%), COVID-19 (14%), fall (13%), and headache (13%). Serious AEs were reported by 17% of donanemab-treated patients. To make it worse, in TRAILBLAZER-ALZ clinical trial, 27.5 % experienced ARIA-E and 30.5% of donanemab patients had ARIA-H. Alzheimer's Association should not wait to recommend interventions. Plenty of nonpharmaceutical interventions have been proven to be significantly more effective than Donanemab in well-designed clinical trials. Some even reversed the cognitive decline.

Breaking News: The FDA has granted approval of Kisunla (donanemab) for the treatment of people living with early symptomatic Alzheimer’s disease. Early symptomatic Alzheimer’s disease significantly impacts individuals by marking the onset of cognitive decline, which can affect daily functioning and independence. Early diagnosis and intervention, as highlighted by the FDA's approval of treatments like Kisunla (donanemab), aim to slow this decline, offering individuals more time and potentially better quality of life. #unitedseniorassociation #USA #eldercare #FDA #NCON #seniorliving #ADA #AI #NIH #patientcare #compliance #hospitals #OIG #healthcare #HHSOIG #digitalhealth #HSS #CMS #assistedliving #AMA #NCN #nursinghomes #seniorcare #medicare #seniorcitizen #homehealthcare #caregiver #dementia #inhomecare #seniorhealth #kloekorby #alzheimers #mentalhealth

The latest advancements in treatment and prevention are so hopeful. 💜

Rare diseases have a large impact on the lives they affect. Today is National Rare Disease Day, and we are shedding light on the 1 in 10 Americans who are living with them. There are hundreds of rare immunodeficiencies, so it's important to seek a medical professional if you are experiencing several of these symptoms, especially frequent, long-lasting infections. Vital Care offers IV therapy to treat certain diseases. Ask your doctor if IV therapy is right for you. #infusiontherapy #specialtypharmacy #stelara #ivinfusion #infusions #infusion #crohnsdisease #InfusionPharmacy #pharmacy #ulcerativecolitis #plaquepsoriasis #psoriaticarthritis #psoriasis #vitalcare

𝐅𝐃𝐀 𝐀𝐩𝐩𝐫𝐨𝐯𝐞𝐬 𝐃𝐨𝐧𝐚𝐧𝐞𝐦𝐚𝐛: 𝐀 𝐌𝐢𝐥𝐞𝐬𝐭𝐨𝐧𝐞 𝐢𝐧 𝐀𝐥𝐳𝐡𝐞𝐢𝐦𝐞𝐫'𝐬 𝐓𝐫𝐞𝐚𝐭𝐦𝐞𝐧𝐭 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/dsuJKU7v Discover how the FDA's approval of donanemab offers new hope in slowing 𝐀𝐥𝐳𝐡𝐞𝐢𝐦𝐞𝐫'𝐬 disease progression. Learn about its groundbreaking potential and what it means for patients and families. #alzheimersresearch #fdaapproval #donanemab #neurologynews #medicalbreakthrough

Rare diseases have a large impact on the lives they affect. Today is National Rare Disease Day, and we are shedding light on the 1 in 10 Americans who are living with them. There are hundreds of rare immunodeficiencies, so it's important to seek a medical professional if you are experiencing several of these symptoms, especially frequent, long-lasting infections. Vital Care offers IV therapy to treat certain diseases. Ask your doctor if IV therapy is right for you. https://bit.ly/3LI0Tet #infusiontherapy #specialtypharmacy #stelara #ivinfusion #infusions #infusion #crohnsdisease #InfusionPharmacy #pharmacy #ulcerativecolitis #plaquepsoriasis #psoriaticarthritis #psoriasis #vitalcare

The oral S1P modulator, approved to treat ulcerative colitis and MS, missed its primary endpoint in the first of two Phase III induction studies in moderate-to-severe Crohn’s disease. https://lnkd.in/erRSdvC5

Rare Disease Day takes place on February 29 this year. Read the new blog to discover how regulatory approvals for rare diseases follow a unique trajectory compared to medicines for common illnesses, with more flexibility in regulatory pathways. Discover how biotechs can use this flexibility to their advantage during trial design. https://ow.ly/W4iT50QHR1T #RareDiseaseDay