Claritas Rx’s Post

GSK announces positive results from phase III severe asthma trials of #depemokimab :- •Primary endpoints met in SWIFT-1 and SWIFT-2 trials with statistically significant and clinically meaningful reductions in exacerbations over 52 weeks vs. placebo. •Depemokimab has the potential to be the first approved ultra-long-acting biologic with a six-month dosing schedule for severe asthma. •Six-month dosing could simplify treatment to support millions of patients with severe asthma.

GSK announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by blood eosinophil count. Both SWIFT-1 and SWIFT-2 met their primary endpoints of a reduction in the annualised rate of clinically significant exacerbations (asthma attacks) over 52 weeks. Patients treated with either depemokimab or placebo experienced similar overall incidence and severity of treatment-emergent adverse events across both trials. Further analysis of these data is ongoing. Read More: https://lnkd.in/gAJDe6WV Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said: “These results add to the established body of evidence that targeted inhibition of IL-5 plays a key role in reducing type 2 inflammation that drives severe asthma exacerbations. Depemokimab could offer the possibility of sustained inhibition of this pathway, with a dosing schedule of just two injections per year. This is important as research shows that 73% of physicians believe longer dosing intervals would be beneficial to patients who are often juggling multiple therapies.” Depemokimab is currently not approved anywhere in the world. #mededgemea #GSK #asthmatreatment #severeasthma #depemokimab #biologictherapy #respiratoryhealth #asthmacare #IL5Inhibition #MedicalBreakthrough #chronicillness #HealthInnovation #pharmanews #clinicaltrials #HealthcareAdvancements

🌬️ Long-Term Path with Biologics: A Guide for Severe Asthma Management 🌟 For those battling severe asthma, biologic therapies have transformed the journey to better breathing and improved quality of life. These advanced treatments offer new hope but come with important considerations for patients and healthcare providers. 🧬 The Benefits of Biologics: Targeted Treatment: Focuses on specific pathways to reduce asthma flare-ups. Fewer Exacerbations: Leads to fewer hospital visits and better asthma control. Steroid-Sparing: Reduces the need for oral corticosteroids. Improved Quality of Life: Enhances daily living by improving lung function and reducing symptoms. 🤔 Navigating Biologic Therapies: Long-Term Safety: Sustained benefits with low rates of adverse events. Switching or Stopping: Must be carefully evaluated with your healthcare team. Stay informed and work closely with your healthcare provider to make the best choices for your asthma management! #Asthma #BiologicTherapies #HealthCare #AsthmaManagement #BreatheEasy #PatientCare https://lnkd.in/g5wQguWv

GSK’s Depemokimab has the potential to be the first approved “ultra-long-acting biologic” with a six-month dosing schedule for severe asthma. Depemokimab has demonstrated statistically significant and clinically meaningful reductions in exacerbations over 52 weeks vs. placebo in the phase III SWIFT trials. Six-month dosing (just 2 injections per year) could simplify treatment to support millions of patients with severe asthma. For more information click the link below. https://lnkd.in/dFkFkBup #Asthma #longactingbiologic #GSK #innovations #SWIFTtrial #PhaseIIItrial

🌬️🔬 Positive Results for Yupelri in COPD Phase III Trial Viatris and Theravance Biopharma US, Inc. have released positive data from a Phase III clinical trial for Yupelri (revefenacin), a maintenance therapy for Chronic Obstructive Pulmonary Disease (COPD). Key Findings: The trial, conducted in China with moderate to very severe COPD patients, revealed that Yupelri demonstrated a statistically significant increase in trough forced expiratory volume in one second (FEV₁) compared to the placebo. The primary efficacy analysis at week 12 showed a mean difference of 150.9ml versus placebo in trough FEV₁, meeting the trial's primary endpoint. Yupelri, a long-acting muscarinic antagonist administered as a once-a-day nebulized dose, has exhibited comparable efficacy and safety to its US clinical data. The study's consistent improvement in lung function supports the use of Yupelri as a foundational therapy for COPD patients. The success of Yupelri marks a significant step toward providing valuable treatment options for COPD patients, emphasizing the commitment to respiratory health innovation. 🌍💨 #COPD #RespiratoryHealth #MedicalAdvancements #ClinicalTrials

The FDA's approval of Winlevair for Pulmonary Arterial Hypertension (PAH) marks a significant breakthrough, offering hope to those with limited treatment options. This achievement underscores: 1. Clinical Trials' Vital Role: The development of Winlevair through rigorous clinical trials showcases the indispensable process of bringing safe, effective treatments to market. 2. Addressing Unmet Needs: Winlevair provides a solution for PAH, a condition with previously few treatment avenues, emphasizing our industry's focus on meeting critical patient needs. 3. Importance of Phase 4 Studies: Ongoing post-approval studies will ensure Winlevair's safety and efficacy, highlighting the commitment to patient well-being through continuous monitoring for rare adverse events. I'm excited to see how this approval changes the current treatment, prognosis and well-being of patients with cardiovascular and pulmonary diseases.

🚨Novo Nordisk has successfully closed its kidney outcomes trial for Ozempic®️. With this major milestone, they can now continue to further their mission of improving the lives of people living with diabetes and their families. Ozempic®️ is a once-weekly GLP-1 receptor agonist that helps to control blood sugar levels in adults with type 2 diabetes. The kidney outcomes trial was conducted to assess the cardiovascular safety of Ozempic®️. The results of the trial showed that Ozempic®️ reduced the risk of major adverse cardiovascular events in patients with type 2 diabetes. #Ozempic #NovoNordisk #Type2Diabetes

First & Only Two-Component Therapy for adults living with Late-onset Pompe Disease U.S. Food and Drug Administration (FDA) has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules. This two-component therapy is indicated for adults living with late-onset Pompe disease (LOPD) weighing ≥40 kg and who are not improving on their current enzyme replacement therapy (ERT). Pompe disease is an inherited lysosomal disorder caused by deficiency of the enzyme acid alpha-glucosidase (GAA). Reduced or absent levels of GAA lead to accumulation of glycogen in cells, which is believed to result in the clinical manifestations of Pompe disease. Pompe disease ranges from a rapidly deteriorating infantile form with significant impact to heart function, to a more slowly progressive, late-onset form primarily affecting skeletal muscle and progressive respiratory involvement. Late-onset Pompe disease can be severe and debilitating with progressive muscle weakness throughout the body that worsens over time, particularly skeletal muscles and muscles that control breathing. https://lnkd.in/e3xv5BXG

Are you ready for a quick lesson on the progression of Type 1 diabetes & a drug called Teplizamaub (Tzield) used to delay its progression? I’m not a medical professional. Please keep that in mind. Stage 1 of Type 1 diabetes is characterized by having the presence of 2 or more islet autoantibodies; Stage 2 is marked by the state of dysgylemia; and Stage 3 is determined by insulin dependency due to the pancreas being under attack (autoimmune disease) and is therefore unable to produce much if any insulin whatsoever. The drug Tzield has been shown to slow down the progression of T1D in Stage 2 of this disease. It can delay the progression of T1D by up to 2 years. But there are other advantages known to taking this drug. According to the article: “Now, the PROTECT study has evaluated whether it could also preserve the function of beta cells—which produce insulin—in recently diagnosed youth. The randomized phase 3 trial found that teplizumab did achieve this, but that trial also suggested that there was improvement in other clinical parameters including reduced reliance on insulin medications, higher grade hypoglycemia, time in range of glucose, and quality of life. The researchers published their findings in the New England Journal of Medicine on October 18.” We’re living in exciting times due to the advances associated with Tzield!

Phase 2 Study Demonstrates Oral Rilzabrutinib Reduces Loss of Control Events in Patients With Asthma: According to the investigators, these findings support the investigation of rilzabrutinib in patients with asthma in a phase 3 trial program. #finance #pharmacy #lifesciences