Acticor Biotech’s Post

02/07/2024 — The U.S. FDA approved a donanemab-azbt injection (Kisunla, Eli Lilly) for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease. Kisunla is to be administered as an IV infusion every 4 weeks. The application was granted Fast Track, Priority Review, and Breakthrough Therapy designations. Amyloid imaging technology has linked excess extracellular Aβ peptide with the development of Alzheimer’s disease. Overproduction of the Aβ peptide disrupts normal neurotransmission as it creates a plaque in certain areas of the brain. Donanemab attacks this plaque build-up to slow the progression of Alzheimer’s disease. #regulatoryupdates #breakthroughtherapy #alzheimer’s https://lnkd.in/gE8iviXT

Exciting developments in cardiovascular research! A recent study has introduced a new blood-thinning drug, abelacimab, which significantly reduces bleeding risks in patients with atrial fibrillation compared to the standard treatment, Xarelto. The trial, involving 1,287 patients, demonstrated that abelacimab reduced bleeding requiring hospitalization by up to 69% and decreased gastrointestinal bleeding by 93%. These promising results led to the early termination of the study. 👉 For the full article, read more here: https://lnkd.in/gjJ-tAxk #CardiovascularResearch #AtrialFibrillation #PatientCare #ClinicalTrials

Perioperative Administration of Cystine and Theanine Suppresses Inflammation and Facilitates Early Rehabilitation and Recovery after Esophagectomy: A Randomized, Double-Blind, Controlled Clinical Trial. Nutrients. 2022 May 31;14(11):2319. A randomized, double-blind, placebo-controlled trial investigated the effects of oral cystine and theanine on recovery after esophagectomy in 32 patients. Participants received perioperative oral cystine and theanine or placebo for 4 and 13 days. Main outcomes included accelerometer readings, inflammation indicators, a 6-minute walk test (6MWT), and a quality of life questionnaire (QoR-40). Although patient activity was better in the oral cystine and theanine group (n=16), differences weren’t statistically significant. Notably, inflammation markers like white blood cell count and C-reactive protein were significantly lower in the oral cystine and theanine group, which also showed improved 6MWT and QoR-40 scores, suggesting enhanced recovery through inflammation suppression. https://lnkd.in/dbcgPZ9n

🥼 Genetesis enroled the first patient, marking the start of its magnetocardiography as a non-invasive diagnostic strategy for suspected myocardial ischemia with the absence of obstructive coronary artery disease (MICRO2) trial. It aims to validate the use of magnetocardiography for detecting myocardial ischemia due to underlying coronary artery obstruction. 💬 Product development vice-president Rhea Malhotra said: “Many of the patients we speak to who suffer from CMD often describe a diagnostic journey that begins with being told their symptoms are non-cardiac due to a negative result on CCTA or invasive angiography. Unfortunately, these patients are being told something that is later proven to be untrue. Offering these patients a 90-second diagnostic option for ischemia that could be used at the beginning of this diagnostic journey would be a huge step forward in fixing this unmet clinical need today.” 👉 Learn more: https://lnkd.in/dP96bKuc 📰 Follow Guided Solutions to receive the latest #MedTech news daily and subscribe to our weekly newsletter: https://lnkd.in/dgfUaW3J #MedicalDevices #MedicalDevice #MedicalEquipment #Medicine #HealthTech #Surgeons #GuidedSolutions

Bruce Sands, MD, discusses his research regarding the use of mirikizumab in patients with moderately to severely active Crohn's disease in order to induce clinical remission and endoscopic response in this patient population. “The study was very rigorously performed and was one of the largest phase 3 Crohn’s studies ever done. There were over 1,000 patients because, not only were they comparing the drug to placebo, but also sort of independently, they were comparing to ustekinumab. The primary outcome was comparison to placebo, for those complex composite outcomes. And it was clearly superior to placebo in all those outcomes and all the key secondary outcomes.” - Dr. Bruce Sands Mount Sinai Department of Medicine #CrohnsDisease #Mirikizuma #ClinicalRemission #EndoscopicResponse #CrohnsResearch #Phase3Study #MountSinaiMedicine https://lnkd.in/eE_M2T2S

🌟 Bayer Unveils Groundbreaking Finerenone Data at CVCT 2024! 🌟 Key insights reveal that Finerenone may significantly enhance blood pressure management in heart failure patients, potentially reducing outpatient worsening heart failure events. Notably, patients with higher BMI could experience even greater benefits! 📉💪 Join Bayer at the Cardiovascular Clinical Trials Forum in Washington, D.C., from December 9-11, 2024, as they present pivotal findings from the Phase III FINEARTS-HF trial. This includes a comprehensive pooled analysis across three Phase III trials that sheds light on finerenone’s safety and effectiveness for heart failure with varying ejection fraction levels. With a focus on innovative treatments for cardiovascular and kidney diseases, Bayer is committed to addressing unmet medical needs. These insights could reshape future treatment guidelines and enhance patient care strategies. Stay tuned for more updates! Click the link to learn more about this exciting development. #Bayer #CVCT2024 #CardiovascularHealth #ClinicalResearches #Finerenone #HeartFailure #MedicalInnovation #PharmaceuticalCompanies #MarketAccess #MarketAccessToday

10/28/24: SPYRAL HTN-ON MED Study Update | Shows significant, consistent, long-term blood pressure lowering effect at two years "These findings are a key step toward informing the medical community of the long-term effectiveness with radiofrequency renal denervation as a treatment for uncontrolled hypertension," stated Dr. David Kandzari, Chief of Piedmont Heart Institute and Cardiovascular Services and lead principal investigator of the SPYRAL HTN-ON MED trial. "Importantly, at two years, we continue to see Symplicity is safe and consistent with clinically meaningful and significant blood pressure reductions. These data further substantiate sustained blood pressure reductions consistently observed in across the SPYRAL and Global Symplicity clinical programs." Medtronic https://lnkd.in/eKxtBqHr

The importance of the patient voice in healthcare decision-making and drug development continues to rise. This multi-stakeholder Voice of the Patient (VOP) meeting brought together patients living with pulmonary hypertension associated with interstitial lung disease (PH-ILD), primary caregivers, patient associations, clinical experts, sponsor representatives, and a meeting facilitator (which was my role). It has been a great pleasure to contribute to this important qualitative research in PH-ILD, and I look forward to being involved in future patient-centred research and publications. Foremost, I gratefully acknowledge the valuable contributions of the participating patients and caregivers who openly shared their lived experiences, without whom this VOP meeting and qualitative research would have been impossible to carry out. Enormous thanks go to the entire group of co-authors, who all made substantial contributions, facilitating the meeting, recruiting and consenting patients and caregivers, improving the qualitative analysis, the discussion and the overall paper step by step: Lucilla Piccari, Gabor Kovacs, Steve Jones, Hall Skaara, Claudia Roca Herms, Gabriela Bacchini Jeanneret, Melqui Calzado, Nuria Gonzalez-Rojas, Míriam Fernández Delgado, and Héctor Gálvez García, Ph.D. And a big thank you to Ferrer (Ferrer Internacional, S.A.) whose financial support enabled the VOP meeting and this publication. These patient insights are essential to support the patient‐centred design of future clinical trials, observational studies, and registries in PH‐ILD, so that research can incorporate what matters most to patients and carers and effectively address unmet medical and patient needs. This is an open access publication available as a PDF download including supplemental materials at the link. KEYWORDS #healthrelatedqualityoflife, #interstitial #lung #disease, #qualityoflife, #patientexperiencedata, #patientinvolvement, #pulmonary #hypertension. #patientcentricity, #qualitativeresearch, #diagnosis, #treatment, #outcomes, #healthcare, #patientreportedoutcomes

New study out today in collaboration with folks from the FDA. We analyzed changes in dispensing and LFT monitoring after the boxed hepatotoxicity warning and LFT monitoring requirement on ambrisentan were removed in 2011. The background for the study is: Ambrisentan is a commonly used medication for pulmonary arterial hypertension and, when approved in 2007, carried a boxed hepatotoxicity warning and LFT monitoring requirement because earlier endothelin receptor antagonists (bosentan and sitaxentan) were associated with well-documented liver injury. But, by 2011, as further safety data emerged, it became clear that ambrisentan was different from the other endothelin receptor antagonists. So the FDA removed the boxed hepatotoxicity warning and REMS (risk evaluation and mitigation strategy) LFT requirement on ambrisentan while leaving it in place for bosentan. We leveraged this unique situation to study prescribing and monitoring of ambrisentan and bosentan following the changes to the ambrisentan labelling in 2011. We observed increased use of ambrisentan and decreased use of bosentan following these changes. We also saw decreased LFT monitoring for ambrisentan with no change for bosentan. However…LFT monitoring for bosentan remained suboptimal during the study period (w/ < 80% getting LFTs checked before initiation and < 65% before the first refill). We conclude that further clinician education may be needed to maximize the benefits of REMS programs and labeling warnings designed to protect patients and ensure the safe administration of high-risk medications. Great to work on this project with Mufaddal Mahesri, MD, MPH, Ameet Sarpatwari, Krista Huybrechts, Yanmin Zhu, Catherine Wang, Joyce Lii, Su Been Lee, Sushama Kattinakere Sreedhara, Gita A. Toyserkani, PharmD MBA, Zhou Esther, Laura Zendel, Cynthia LaCivita, Claudia Manzo, Gerald Dal Pan, Aaron S. Kesselheim, M.D., J.D., M.P.H. and Katsiaryna Bykov. https://lnkd.in/g9yGHrHH

J&J's Tremfya approval in ulcerative colitis yesterday sets up an intriguing competitive case study vs. AbbVie's Skyrizi in UC. While there are nuances to each therapy's mechanism of action, they both fall under the general IL-23 umbrella. Additionally, while no two clinical studies are the same, 45% of patients receiving Tremfya 100 mg SC every eight weeks reached clinical remission at week 44 (see press release), while an identical 45% of patients receiving Skyrizi 180 mg SC every eight weeks achieved clinical remission at week 52 (see Skyrizi HCP website). No notable side effect stands out from the other either. Both therapies provide an important option for UC patients, so it will be interesting to see how they can differentiate from each other. It is likely that levels of insurance coverage, patient support and the types of administration device will take on an added importance in highlighting salient differences between the 2 agents. #gastroenterology #ulcerativecolitis #fdaapproval #inflammatoryboweldisease