Skills Alliance’s Post

Study: Tezepelumab Reduces Annual Rates of Exacerbations Related to COPD: For patients with a blood eosinophil count of 150 cells/µL or greater, tezepelumab had a significant reduction of approximately 37% in the rate of moderate or severe exacerbations. #finance #pharmacy #lifesciences

Impactful #Newdrugapproval alert! At the end of March, Winrevair (sotatercept-csrk) was approved for the treatment of adults with pulmonary arterial hypertension (PAH). This is considered the first disease-modifying agent as current treatments are for symptom control with some potentially slowing progression. Winrevair will target the underlying causes and balance the pro and anti-proliferative signaling pathways which can reverse vascular and right ventricle remodeling. In studies, the 6-minute walk increased but it also was associated with lower risk of all-cause death and non-fatal worsening of PAH. Well tolerated, but side effects related to the increase in hemoglobin, including clotting events, so monitoring of hemoglobin and platelets before at least the first 5 doses is required. Winrevair is a subcutaneous injection that can be self-injected at home every 3 weeks and is expected to be available end of April 2024 through select specialty pharmacies. Pricing is a hit with ranges at either $240,000 or $480,000 per year based on weight. It is anticipated that this will be add on therapy to current dual or triple therapy adding to the overall cost of care in PAH. Of note, ICER put the cost benefit at $17,900-$35,400 per year, so BIG disconnect! https://lnkd.in/g5ektX2c #Pharmacists #Pharmacybenefits #Newdrugs #PAH #Clinicalpharmacy

Tezepelumab in COPD Phase 2 COURSE TRIAL top line results   https://lnkd.in/eHJq9rqN Teze 420mg q4wk vs placebo in COPD over 12 mo  For primary EP of mod-sev exac overall = 17% relative reduction Not Sig (N=333) Absolute reduction = 0.36/yr Ie need to Rx for 3 yr to prevent an exac with Teze   Eos≥150/ul =37% (CI 7 to 57) relative reduction Sig (N=137) Need to Rx for 1.14 yr to prevent an exac with Teze   Eos≥300/ul =46% (CI -15 to 75) relative reduction Not sig (N=56) Need to Rx for 0.96 yr to prevent an exac with teze   Eos<150/ul = -19% (CI-90 to 25) relative increase Not sig (N=137) Need to Rx for 3 yr to induce an exac with Teze   Conclusion   A bit of a son in law result tbh   Overall  Teze was futile in terms of mod-sev exacerbation reduction Although not powered a priori to look at eosinophil subgroups there was a significant reduction for pts with Eos≥300/ul   There was a non sig worsening of exac in T2 low pts with Eos<150/ul   Need to wait for phase 3 study with larger numbers to work out impact of Teze in T2H incl the effect in pts who are FeNO high  

📣 Exciting news in the medical field! The U.S. FDA has approved Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection. This marks a significant step forward in treating adults with relapsing forms of multiple sclerosis (MS) and Crohn’s Disease (CD). 💪 💉 Biosimilar medications like Tyruko offer additional effective treatment options, potentially increasing access for people with these conditions. The approval of Tyruko is based on evidence that there are no clinically meaningful differences between it and Tysabri in terms of safety, purity, and potency. 📝 💝 This approval further supports the FDA’s commitment to a competitive marketplace for biological products, ultimately empowering patients by helping to increase access to safe, effective, and high-quality medications at potentially lower costs. 💰 ✔ The approval of Tyruko is a significant milestone in the ongoing fight against MS and CD. However, it's important to note that due to the risks of progressive multifocal leukoencephalopathy (PML), a viral brain infection, natalizumab products are available only through a restricted drug distribution program under a risk evaluation and mitigation strategy (REMS). ⚠ 🎉 Congratulations to Sandoz Inc. on this achievement! 👏 For more information on this update, check out the link - https://lnkd.in/debJeqhk #fda #multiplesclerosis #crohnsdisease #biosimilar #healthcare #medicine #innovation

Drug combinations rather than increasing doses of one drug can achieve greater efficacy and lower risks! Among patients with ASCVD, moderate-intensity statin with ezetimibe combination therapy was non-inferior to high-intensity statin monotherapy for the 3-year composite outcomes. Higher proportion of patients on Statin + Ezetimibe had LDL cholesterol concentrations of less than 70 mg/dL and lower intolerance-related drug discontinuation or dose reduction. #statins #medtwitter #endotwitter #heartdisease #cholesterol https://lnkd.in/dDTk-7rz

This week, a selection of expanded #pharmacotherapy topics w/ #PMT #JPharmTechnol - novel treatments of crizanlizumab for #sicklecelldisease (Stevens et al https://lnkd.in/eAg33zxa ) + lasmiditan for acute #migraine (Beauchene & Levien https://lnkd.in/esBCGHWA) #pharmacists #womenshealth #diseasemanagement #monoclonalantibodies

The REDUCED-1 study of SoniVie Ltd's TIVUS renal denervation system for hypertension treatment—an FDA investigational device exemption (IDE)-approved pilot study—has recently completed enrolment. SoniVie's CMO, Christian Spaulding, has stated that the the “initial results from the ongoing REDUCED-1 study are encouraging," and CEO Tomaso Zambelli also stated that their next step will be to “clinically validate the TIVUS system in a global pivotal trial”. To learn more about this, click the link below to read the full article! #renaldenervation #hypertension

𝐙𝐲𝐝𝐮𝐬 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐠𝐞𝐭𝐬 𝐂𝐃𝐒𝐂𝐎 𝐏𝐚𝐧𝐞𝐥 𝐍𝐨𝐝 𝐓𝐨 𝐬𝐭𝐮𝐝𝐲 𝐅𝐃𝐂 𝐄𝐦𝐩𝐚𝐠𝐥𝐢𝐟𝐥𝐨𝐳𝐢𝐧 𝐩𝐥𝐮𝐬 𝐌𝐞𝐭𝐨𝐩𝐫𝐨𝐥𝐨𝐥 𝐒𝐮𝐜𝐜𝐢𝐧𝐚𝐭𝐞 📌Zydus Healthcare has got approval from the Subject Expert Committee (SEC) functional under the CDSCO to conduct the bioequivalence (BE) study of the fixed-dose combination (FDC) ◾Empagliflozin 10mg/10mg plus Metoprolol Succinate IP 23.75mg eq. to Metoprolol Tartrate (ER) 25mg/ Metoprolol Succinate IP 47.50mg eq. to Metoprolol Tartrate (ER) 50mg uncoated bilayered tablet. 📌Empagliflozin is a medication used in the management and treatment of type 2 diabetes mellitus. 📌Metoprolol is a cardioselective beta-1-adrenergic receptor inhibitor that competitively blocks beta1 receptors with minimal or no effects on beta-2 receptors at oral doses of less than 100 mg in adults. ◾The expert panel suggested that the firm should submit a BE study report for review by the committee and for taking further decisions on the Phase III clinical trial protocol. #zydus #cdsco #diabetes

Clinical Trials Updates: Viatris and Theravance Biopharma US, Inc. announce positive phase III results for COPD phase III trial in China Viatris Inc. and Theravance Biopharma, Inc. have reported positive top-line results from a Phase III trial of YUPELRI® (revefenacin) in China for treating Chronic Obstructive Pulmonary Disease (COPD). The trial demonstrated the efficacy and safety of YUPELRI, a once-daily nebulized long-acting muscarinic antagonist. The primary efficacy endpoint, an increase in trough FEV1 (forced expiratory volume in one second), showed statistical significance compared to the placebo. The results align with U.S. clinical data, supporting a comparable efficacy and safety profile for YUPELRI. With nearly 100 million individuals affected by COPD in China, the findings highlight the potential of YUPELRI as a therapeutic option. The companies plan to file for regulatory approval in China in mid-2024. #Medicalaffairs #clinicaldevelopment #COPD #Clinicalprofessionals #clinicalcareers https://lnkd.in/e-ke2bjF

Boehringer and Lilly’s Jardiance granted MHRA approval to treat chronic kidney disease Approximately 7.2 million people in the UK are affected by the long-term kidney condition Boehringer Ingelheim and Eli Lilly's Jardiance (empagliflozin) has been approved by the Medicines and Healthcare products Regulatory Agency (MHRA) as a treatment option for adults with chronic kidney disease (CKD). Approximately 7.2 million people in the UK are affected by CKD, a long-term condition characterised by a gradual loss of kidney function. With CKD mostly being asymptomatic until the later stages of the condition, most patients go undiagnosed, and every year, up to 45,000 people in the UK die prematurely from CKD and its related complications, including hypertension, diabetes, obesity, primary renal disorders and anaemia. Jardiance, which is already approved in the UK to treat type 2 diabetes and heart failure, is a once-daily oral inhibitor of the sodium glucose co-transporter-2 that works by increasing sugar lost in the urine. https://lnkd.in/gsuycAqW